Trial Outcomes & Findings for A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (NCT NCT03962738)
NCT ID: NCT03962738
Last Updated: 2021-06-11
Results Overview
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
846 participants
Primary outcome timeframe
2 Hours Postdose
Results posted on
2021-06-11
Participant Flow
A participant who was randomized but did not treat with the study intervention was considered to have completed the study if they did not discontinue throughout the 8 weeks of treatment period and attended Visit 3 End of Study (EoS) or Early Discontinuation (EDC).
Participant milestones
| Measure |
Placebo
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once to treat a single migraine attack.
|
50 Milligrams (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
258
|
109
|
261
|
218
|
|
Overall Study
Received At Least One Dose of Study Drug
|
214
|
87
|
208
|
182
|
|
Overall Study
COMPLETED
|
251
|
109
|
259
|
217
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once to treat a single migraine attack.
|
50 Milligrams (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Overall Study
Protocol Deviation
|
3
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=214 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
50 mg Lasmiditan
n=87 Participants
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=208 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=182 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
Total
n=691 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 8.95 • n=93 Participants
|
44.9 years
STANDARD_DEVIATION 10.20 • n=4 Participants
|
45.7 years
STANDARD_DEVIATION 9.66 • n=27 Participants
|
44.7 years
STANDARD_DEVIATION 10.36 • n=483 Participants
|
45.2 years
STANDARD_DEVIATION 9.70 • n=36 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
145 Participants
n=483 Participants
|
574 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
117 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
214 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
182 Participants
n=483 Participants
|
691 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Japan
|
214 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
182 Participants
n=483 Participants
|
691 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug to treat a migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=211 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=179 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
|
16.6 percentage of participants
|
40.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=211 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=85 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=207 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=179 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Headache Pain Free in Each Dose Group
|
16.6 percentage of participants
|
23.5 percentage of participants
|
32.4 percentage of participants
|
40.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=211 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=85 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=207 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=179 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With Headache Pain Relief
|
55.0 percentage of participants
|
68.2 percentage of participants
|
80.2 percentage of participants
|
78.2 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments. Participants with no symptoms at pre-dose were excluded from the analysis.
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as "nonresponder."
Outcome measures
| Measure |
Placebo
n=157 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=59 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=150 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=121 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
|
46.5 percentage of participants
|
55.9 percentage of participants
|
58.0 percentage of participants
|
60.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Outcome measures
| Measure |
Placebo
n=212 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=87 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=208 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=180 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With 24-Hour Sustained Pain Freedom
|
10.4 percentage of participants
|
14.9 percentage of participants
|
20.2 percentage of participants
|
23.2 percentage of participants
|
SECONDARY outcome
Timeframe: 48 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Outcome measures
| Measure |
Placebo
n=212 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=87 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=208 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=180 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With 48-Hour Sustained Pain Freedom
|
12.3 percentage of participants
|
14.9 percentage of participants
|
19.7 percentage of participants
|
21.1 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of drug and had any postdose headache severity or symptom assessment.
Percentage of participants that are free of phonophobia at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=208 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=86 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=203 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=171 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants That Are Free of Phonophobia
|
83.7 percentage of participants
|
89.5 percentage of participants
|
87.2 percentage of participants
|
86.5 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
Percentage of participants that are free of photophobia at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=208 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=86 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=203 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=171 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants That Are Free of Photophobia
|
69.2 percentage of participants
|
77.9 percentage of participants
|
76.8 percentage of participants
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
Percentage of participants that are free of nausea at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=208 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=86 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=203 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=171 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants That Are Free of Nausea
|
78.8 percentage of participants
|
83.7 percentage of participants
|
82.3 percentage of participants
|
79.5 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
Percentage of participants that are free of vomiting at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=208 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=86 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=203 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=171 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants That Are Free of Vomiting
|
99.0 percentage of participants
|
97.7 percentage of participants
|
99.5 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 Hour PostdosePopulation: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
Percentage of participants with pain freedom.
Outcome measures
| Measure |
Placebo
n=211 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=85 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=207 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=179 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With Pain Freedom
|
1.4 percentage of participants
|
4.7 percentage of participants
|
11.6 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: 1 Hour PostdosePopulation: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
Percentage of participants with headache pain relief at 1 hour postdose.
Outcome measures
| Measure |
Placebo
n=211 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=85 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=207 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=179 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With Headache Pain Relief
|
41.2 percentage of participants
|
35.3 percentage of participants
|
58.5 percentage of participants
|
59.8 percentage of participants
|
SECONDARY outcome
Timeframe: 1 Hour PostdosePopulation: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.
Outcome measures
| Measure |
Placebo
n=157 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=59 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=150 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=121 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
|
28.7 percentage of participants
|
32.2 percentage of participants
|
42.0 percentage of participants
|
33.1 percentage of participants
|
SECONDARY outcome
Timeframe: 1 Hour PostdosePopulation: All randomized participants who received one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.
Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose.
Outcome measures
| Measure |
Placebo
n=209 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=81 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=199 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=173 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With No Disability
|
8.1 percentage of participants
|
13.6 percentage of participants
|
10.6 percentage of participants
|
12.1 percentage of participants
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.
Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=206 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=85 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=201 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=171 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With No Disability
|
18.4 percentage of participants
|
24.7 percentage of participants
|
25.4 percentage of participants
|
28.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=75 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=176 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=150 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
|
0.200 score on a scale
Standard Deviation 0.218
|
0.192 score on a scale
Standard Deviation 0.192
|
0.224 score on a scale
Standard Deviation 0.198
|
0.186 score on a scale
Standard Deviation 0.192
|
SECONDARY outcome
Timeframe: Baseline, 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Outcome measures
| Measure |
Placebo
n=186 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=75 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=176 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=150 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
|
20.785 score on a scale
Standard Deviation 26.094
|
19.640 score on a scale
Standard Deviation 25.927
|
21.341 score on a scale
Standard Deviation 26.920
|
19.320 score on a scale
Standard Deviation 24.860
|
SECONDARY outcome
Timeframe: 2 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.
Outcome measures
| Measure |
Placebo
n=212 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=87 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=208 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=180 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
|
23.6 percentage of participants
|
35.6 percentage of participants
|
44.7 percentage of participants
|
48.3 percentage of participants
|
SECONDARY outcome
Timeframe: 24 Hours PostdosePopulation: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.
Outcome measures
| Measure |
Placebo
n=187 Participants
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=74 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=177 Participants
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=152 Participants
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Work Functioning
|
12.594 score on a scale
Standard Deviation 4.129
|
13.392 score on a scale
Standard Deviation 3.930
|
13.034 score on a scale
Standard Deviation 4.176
|
12.368 score on a scale
Standard Deviation 4.197
|
|
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Social Functioning
|
13.235 score on a scale
Standard Deviation 4.915
|
13.865 score on a scale
Standard Deviation 4.336
|
13.429 score on a scale
Standard Deviation 4.857
|
13.118 score on a scale
Standard Deviation 4.803
|
|
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Energy and Vitality
|
12.652 score on a scale
Standard Deviation 4.412
|
12.905 score on a scale
Standard Deviation 4.224
|
12.723 score on a scale
Standard Deviation 4.580
|
12.309 score on a scale
Standard Deviation 4.277
|
|
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Feelings and Concerns
|
11.674 score on a scale
Standard Deviation 4.145
|
11.622 score on a scale
Standard Deviation 4.190
|
12.028 score on a scale
Standard Deviation 4.181
|
12.099 score on a scale
Standard Deviation 4.197
|
|
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Migraine Symptoms
|
14.070 score on a scale
Standard Deviation 3.870
|
14.703 score on a scale
Standard Deviation 3.877
|
14.949 score on a scale
Standard Deviation 3.544
|
14.895 score on a scale
Standard Deviation 3.754
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
50 mg Lasmiditan
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
100 mg Lasmiditan
Serious events: 0 serious events
Other events: 147 other events
Deaths: 0 deaths
200 mg Lasmiditan
Serious events: 0 serious events
Other events: 147 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=214 participants at risk
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
|
50 mg Lasmiditan
n=87 participants at risk
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
100 mg Lasmiditan
n=208 participants at risk
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
200 mg Lasmiditan
n=182 participants at risk
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
1.4%
3/214 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
4/87 • Number of events 4 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
9/208 • Number of events 10 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
4/182 • Number of events 4 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
4/87 • Number of events 4 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
5/208 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
7/182 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Blepharospasm
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Photophobia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Photopsia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Visual impairment
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Xanthopsia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.93%
2/214 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
3/214 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
5/214 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
7/208 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.7%
5/182 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
5/214 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
3/87 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
11/208 • Number of events 11 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.8%
16/182 • Number of events 17 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
2/214 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
5/208 • Number of events 6 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
5/87 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.7%
14/208 • Number of events 14 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.9%
18/182 • Number of events 18 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chills
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
4/208 • Number of events 4 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/182 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Discomfort
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
5/208 • Number of events 5 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
7/182 • Number of events 8 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.4%
7/208 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/182 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Feeling hot
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Gait disturbance
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Malaise
|
1.4%
3/214 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.9%
6/87 • Number of events 6 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
23/208 • Number of events 24 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.5%
21/182 • Number of events 22 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Swelling
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Thirst
|
0.93%
2/214 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.93%
2/214 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
2/87 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.93%
2/214 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Body temperature increased
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
4/182 • Number of events 4 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
11/208 • Number of events 11 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
7/182 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
3.3%
7/214 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.7%
18/87 • Number of events 18 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
38.0%
79/208 • Number of events 80 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
50.0%
91/182 • Number of events 93 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
2/87 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
12/208 • Number of events 12 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.2%
24/182 • Number of events 25 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
5.1%
11/214 • Number of events 11 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.0%
7/87 • Number of events 7 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.2%
44/208 • Number of events 45 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
22.5%
41/182 • Number of events 41 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/182 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
2/208 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.56%
1/178 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.69%
1/145 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/178 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/176 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.69%
1/145 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/178 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.57%
1/176 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/145 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.93%
2/214 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
1/87 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/182 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.47%
1/214 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/208 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/182 • Number of events 3 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/182 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/214 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/87 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.48%
1/208 • Number of events 1 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/182 • Number of events 2 • Up to 16 weeks
All randomized participants who received at least one dose of study drug regardless of whether they underwent any study assessments. Gender specific events occurring only 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
- Publication restrictions are in place
Restriction type: GT60