Trial Outcomes & Findings for Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (NCT NCT02605174)
NCT ID: NCT02605174
Last Updated: 2019-09-23
Results Overview
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3005 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2019-09-23
Participant Flow
Participants were randomly assigned to 1 of 7 sequences and received lasmiditan 50 mg (L50 mg), lasmiditan 100 mg (L100 mg) or lasmiditan 200 mg (L200 mg) or placebo (P) for the first dose and the second dose, if needed for rescue or recurrence of migraine.
Participant milestones
| Measure |
Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 50 mg/Placebo
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg/Lasmiditan 100 mg
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmitidan 100 mg/Placebo
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmitidan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
501
|
249
|
502
|
252
|
501
|
249
|
751
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
429
|
225
|
423
|
212
|
434
|
215
|
645
|
|
Overall Study
Received Optional 2nd Dose
|
206
|
96
|
177
|
83
|
144
|
74
|
361
|
|
Overall Study
COMPLETED
|
437
|
226
|
426
|
216
|
448
|
217
|
662
|
|
Overall Study
NOT COMPLETED
|
64
|
23
|
76
|
36
|
53
|
32
|
89
|
Reasons for withdrawal
| Measure |
Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 50 mg/Placebo
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg/Lasmiditan 100 mg
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmitidan 100 mg/Placebo
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmitidan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, daily for acute treatment of migraine. An optional second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
20
|
7
|
27
|
10
|
20
|
10
|
29
|
|
Overall Study
Protocol Violation
|
10
|
4
|
14
|
6
|
7
|
7
|
12
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
14
|
11
|
6
|
4
|
15
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Randomization Failure
|
22
|
6
|
20
|
7
|
16
|
11
|
30
|
Baseline Characteristics
Participants in each region are those who were randomized to each arm.
Baseline characteristics by cohort
| Measure |
Lasmiditan 50 mg
n=654 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=635 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=649 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=645 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Total
n=2583 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 13.20 • n=99 Participants
|
43.4 years
STANDARD_DEVIATION 12.59 • n=107 Participants
|
41.8 years
STANDARD_DEVIATION 12.40 • n=206 Participants
|
42.6 years
STANDARD_DEVIATION 12.90 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 12.79 • n=31 Participants
|
|
Sex: Female, Male
Female
|
554 Participants
n=99 Participants
|
539 Participants
n=107 Participants
|
536 Participants
n=206 Participants
|
545 Participants
n=7 Participants
|
2174 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
409 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
106 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
426 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
524 Participants
n=99 Participants
|
509 Participants
n=107 Participants
|
522 Participants
n=206 Participants
|
516 Participants
n=7 Participants
|
2071 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
135 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
532 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
515 Participants
n=99 Participants
|
493 Participants
n=107 Participants
|
511 Participants
n=206 Participants
|
518 Participants
n=7 Participants
|
2037 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
77 Participants
n=99 Participants • Participants in each region are those who were randomized to each arm.
|
79 Participants
n=107 Participants • Participants in each region are those who were randomized to each arm.
|
77 Participants
n=206 Participants • Participants in each region are those who were randomized to each arm.
|
77 Participants
n=7 Participants • Participants in each region are those who were randomized to each arm.
|
310 Participants
n=31 Participants • Participants in each region are those who were randomized to each arm.
|
|
Region of Enrollment
United Kingdom
|
48 Participants
n=99 Participants • Participants in each region are those who were randomized to each arm.
|
48 Participants
n=107 Participants • Participants in each region are those who were randomized to each arm.
|
47 Participants
n=206 Participants • Participants in each region are those who were randomized to each arm.
|
48 Participants
n=7 Participants • Participants in each region are those who were randomized to each arm.
|
191 Participants
n=31 Participants • Participants in each region are those who were randomized to each arm.
|
|
Region of Enrollment
United States
|
625 Participants
n=99 Participants • Participants in each region are those who were randomized to each arm.
|
627 Participants
n=107 Participants • Participants in each region are those who were randomized to each arm.
|
626 Participants
n=206 Participants • Participants in each region are those who were randomized to each arm.
|
626 Participants
n=7 Participants • Participants in each region are those who were randomized to each arm.
|
2504 Participants
n=31 Participants • Participants in each region are those who were randomized to each arm.
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=556 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=532 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=528 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=539 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
|
28.6 percentage of participants
|
31.4 percentage of participants
|
38.8 percentage of participants
|
21.3 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable MBS data.
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=512 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=500 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=483 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=514 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
|
40.8 percentage of participants
|
44.2 percentage of participants
|
48.7 percentage of participants
|
33.5 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable headache relief data.
The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=575 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Headache Relief
|
59.0 percentage of participants
|
64.8 percentage of participants
|
65.0 percentage of participants
|
47.7 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 2 Hours Post Dose Up to 48 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data.
The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)
Outcome measures
| Measure |
Lasmiditan 50 mg
n=159 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=167 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=205 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=115 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Headache Recurrence
|
38 Participants
|
44 Participants
|
52 Participants
|
26 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
The percentage of participants who used rescue medication.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Use of Rescue Medication
|
31.9 percentage of participants
|
26.4 percentage of participants
|
18.9 percentage of participants
|
40.8 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 2 Hours Post Dose Up to 24 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
The percentage of participants who used rescue medication.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Use of Rescue Medication
|
8.9 percentage of participants
|
6.3 percentage of participants
|
7.4 percentage of participants
|
8.7 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 24 Post Dose Up to 48 HoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.
The percentage of participants who used rescue medication.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Use of Rescue Medication
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable nausea free data.
The percentage of participant without nausea.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Nausea Free
|
68.7 percentage of participants
|
71.8 percentage of participants
|
70.4 percentage of participants
|
70.3 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data.
The percentage of participants without phonophobia.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Phonophobia Free
|
61.2 percentage of participants
|
64.8 percentage of participants
|
65.3 percentage of participants
|
53.5 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.
The percentage of participants without photophobia.
Outcome measures
| Measure |
Lasmiditan 50 mg
n=598 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=571 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=565 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=576 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Photophobia Free
|
51.2 percentage of participants
|
56.4 percentage of participants
|
58.2 percentage of participants
|
43.2 percentage of participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine AttackPopulation: All randomized participants who had received at least one dose of study drug and had evaluable resource utilization data.
Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study
Outcome measures
| Measure |
Lasmiditan 50 mg
n=429 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=225 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=423 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=212 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
n=434 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
n=215 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
n=645 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Resource Utilization
6 months prior to enrolling
|
4.7 percentage of participants
|
2.2 percentage of participants
|
2.8 percentage of participants
|
2.4 percentage of participants
|
3.2 percentage of participants
|
3.3 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Resource Utilization
During time of study
|
0.5 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
0.5 percentage of participants
|
0.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline Up to End of Study (Up to 11 Weeks)Population: All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.
Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
Outcome measures
| Measure |
Lasmiditan 50 mg
n=654 Participants
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg
n=635 Participants
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg
n=649 Participants
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Placebo
n=645 Participants
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Lasmiditan 200 mg
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to Lasmiditan 200 mg.
|
Lasmiditan 200 mg/Placebo
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine. Then, participants were assigned to placebo.
|
Placebo/Placebo
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Events
|
167 participants
|
230 participants
|
253 participants
|
75 participants
|
—
|
—
|
—
|
Adverse Events
Lasmiditan 50 mg/Lasmiditan 50 mg
Serious events: 1 serious events
Other events: 118 other events
Deaths: 0 deaths
Lasmiditan 50 mg/Placebo
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Lasmiditan 100 mg/Lasmiditan 100 mg
Serious events: 1 serious events
Other events: 149 other events
Deaths: 0 deaths
Lasmiditan 100 mg/Placebo
Serious events: 1 serious events
Other events: 94 other events
Deaths: 0 deaths
Lasmiditan 200 mg/Lasmiditan 200 mg
Serious events: 3 serious events
Other events: 177 other events
Deaths: 0 deaths
Lasmiditan 200 mg/Placebo
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo/Placebo
Serious events: 2 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lasmiditan 50 mg/Lasmiditan 50 mg
n=429 participants at risk
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 50 mg/Placebo
n=225 participants at risk
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Lasmiditan 100 mg/Lasmiditan 100 mg
n=423 participants at risk
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg/Placebo
n=212 participants at risk
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Lasmiditan 200 mg/Lasmiditan 200 mg
n=435 participants at risk
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Placebo
n=217 participants at risk
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Placebo/Placebo
n=646 participants at risk
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Somatisation disorder
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
Other adverse events
| Measure |
Lasmiditan 50 mg/Lasmiditan 50 mg
n=429 participants at risk
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 50 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 50 mg/Placebo
n=225 participants at risk
Lasmiditan 50 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Lasmiditan 100 mg/Lasmiditan 100 mg
n=423 participants at risk
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 100 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 100 mg/Placebo
n=212 participants at risk
Lasmiditan 100 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Lasmiditan 200 mg/Lasmiditan 200 mg
n=435 participants at risk
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional Lasmitidan 200 mg second dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
|
Lasmiditan 200 mg/Placebo
n=217 participants at risk
Lasmiditan 200 mg was administered orally, once for acute treatment of migraine. An optional placebo second dose was administered between 2 and 24 hours for rescue or recurrence of migraine
|
Placebo/Placebo
n=646 participants at risk
Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered within 24 hours for rescue or recurrence of migraine.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.70%
3/429 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.71%
3/423 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Endocrine disorders
Hyperthyroidism
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Chromatopsia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Keratitis
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Mydriasis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Photopsia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Strabismus
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Vision blurred
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Visual acuity reduced
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Visual impairment
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.47%
2/429 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
12/429 • Number of events 12 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
2.7%
6/225 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.1%
13/423 • Number of events 13 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
4.2%
9/212 • Number of events 9 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.2%
14/435 • Number of events 14 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.8%
4/217 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.4%
9/646 • Number of events 9 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Toothache
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.8%
4/225 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.4%
3/217 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
3/646 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Asthenia
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.9%
4/212 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.8%
8/435 • Number of events 8 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.8%
4/217 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Chills
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Face oedema
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Fatigue
|
3.0%
13/429 • Number of events 13 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.1%
7/225 • Number of events 7 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.1%
13/423 • Number of events 13 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
7.1%
15/212 • Number of events 15 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
4.8%
21/435 • Number of events 21 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
5.5%
12/217 • Number of events 12 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.93%
6/646 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Feeling abnormal
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.71%
3/423 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
4/435 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Feeling cold
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Feeling hot
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Feeling jittery
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Malaise
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Mass
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Peripheral swelling
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Pyrexia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Sense of oppression
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
General disorders
Thirst
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Influenza
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
3/646 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.70%
3/429 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
3/646 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Investigations
Blood pressure increased
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Investigations
Heart rate increased
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Investigations
Pulse pressure increased
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.71%
3/423 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.4%
6/429 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.95%
4/423 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.9%
4/212 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.6%
7/435 • Number of events 7 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Ataxia
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Aura
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Balance disorder
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Dizziness
|
9.1%
39/429 • Number of events 42 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
8.0%
18/225 • Number of events 19 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
18.2%
77/423 • Number of events 84 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
21.2%
45/212 • Number of events 45 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
20.5%
89/435 • Number of events 94 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
15.2%
33/217 • Number of events 33 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
2.5%
16/646 • Number of events 17 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Formication
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Head discomfort
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Headache
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Hypoaesthesia
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.2%
5/423 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
2.4%
5/212 • Number of events 5 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
2.3%
10/435 • Number of events 10 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Lethargy
|
1.6%
7/429 • Number of events 8 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.95%
4/423 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.9%
4/212 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.6%
7/435 • Number of events 7 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.2%
7/217 • Number of events 7 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Myoclonus
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Paraesthesia
|
2.6%
11/429 • Number of events 13 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
3.1%
7/225 • Number of events 7 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
5.0%
21/423 • Number of events 22 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
8.0%
17/212 • Number of events 17 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
6.9%
30/435 • Number of events 34 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
6.0%
13/217 • Number of events 14 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.93%
6/646 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Sedation
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.94%
2/212 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.4%
3/212 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Somnolence
|
5.6%
24/429 • Number of events 25 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
4.9%
11/225 • Number of events 11 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
5.0%
21/423 • Number of events 21 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
4.7%
10/212 • Number of events 10 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
7.8%
34/435 • Number of events 36 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
5.5%
12/217 • Number of events 12 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
2.0%
13/646 • Number of events 13 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Stupor
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Syncope
|
0.23%
1/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Tremor
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
4/435 • Number of events 4 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Nervous system disorders
Vertigo cns origin
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Abnormal dreams
|
0.47%
2/429 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Anxiety
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.4%
6/423 • Number of events 6 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Depersonalisation
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.92%
2/217 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Euphoric mood
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.2%
5/423 • Number of events 5 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Nightmare
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
2/423 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
1.4%
3/212 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.69%
3/435 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
2/435 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal odour
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.44%
1/225 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.23%
1/429 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/646 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Flushing
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.23%
1/435 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
1/217 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.31%
2/646 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Hot flush
|
0.47%
2/429 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.89%
2/225 • Number of events 2 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.24%
1/423 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/212 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.46%
3/646 • Number of events 3 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/429 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/225 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/423 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.47%
1/212 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/435 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.00%
0/217 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
0.15%
1/646 • Number of events 1 • From Baseline Up to End of Study (Up to 11 Weeks)
The safety population includes all participants who received at least one dose of study drug and the optional second dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60