Trial Outcomes & Findings for A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine (NCT NCT00384774)
NCT ID: NCT00384774
Last Updated: 2019-12-02
Results Overview
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2019-12-02
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
4
|
12
|
24
|
28
|
16
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
42
|
4
|
12
|
24
|
28
|
16
|
4
|
|
Overall Study
COMPLETED
|
42
|
4
|
12
|
24
|
28
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Placebo-Controlled Adaptive Treatment Assignment Study of Intravenous COL-144 in the Acute Treatment of Migraine
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
46.8 Years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
39.2 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
34.5 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
38.9 Years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
40.3 Years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
40.8 Years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
39.0 Years
STANDARD_DEVIATION 11.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
113 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
125 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Latin
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
South-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Romanian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Region of Enrollment
Finland
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
29 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
97 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
No
|
23 Participants
|
2 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
Yes
|
19 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
18 Participants
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dosePopulation: All randomized participants who received at least one dose of study drug.
Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
10 min
|
11.9 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
8.3 Percentage of participants
|
14.3 Percentage of participants
|
12.5 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
20 min
|
26.2 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
25.0 Percentage of participants
|
39.3 Percentage of participants
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
40 min
|
35.7 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
37.5 Percentage of participants
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
90 min
|
47.6 Percentage of participants
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
45.8 Percentage of participants
|
53.6 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
240 min
|
31.0 Percentage of participants
|
75.0 Percentage of participants
|
33.3 Percentage of participants
|
54.2 Percentage of participants
|
57.1 Percentage of participants
|
68.8 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
60 min
|
33.3 Percentage of participants
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
50.0 Percentage of participants
|
53.6 Percentage of participants
|
75.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
120 min
|
45.2 Percentage of participants
|
50.0 Percentage of participants
|
16.7 Percentage of participants
|
54.2 Percentage of participants
|
64.3 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
|
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
180 min
|
33.3 Percentage of participants
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
54.2 Percentage of participants
|
60.7 Percentage of participants
|
68.8 Percentage of participants
|
75.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dosePopulation: All randomized participants who received at least one dose of study drug.
Headache free is defined as a reduction in headache severity from moderate or severe at baseline to no headache pain at 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, and 240 min after initiation of study drug.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=27 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=3 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Headache Free
10 min
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.6 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
20 min
|
2.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
3.6 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
120 min
|
19.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20.8 Percentage of participants
|
28.6 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
240 min
|
21.4 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
20.8 Percentage of participants
|
28.6 Percentage of participants
|
31.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
180 min
|
21.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20.8 Percentage of participants
|
32.1 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
40 min
|
2.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
14.3 Percentage of participants
|
18.8 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
60 min
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20.8 Percentage of participants
|
21.4 Percentage of participants
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Headache Free
90 min
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
20.8 Percentage of participants
|
25.0 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the participant diary. Sustained headache response was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Sustained Headache Response
No
|
29 Participants
|
2 Participants
|
11 Participants
|
16 Participants
|
18 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Sustained Headache Response
Yes
|
13 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 to 24 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Sustained pain free was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Sustained Pain Free
No
|
35 Participants
|
4 Participants
|
12 Participants
|
21 Participants
|
23 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Sustained Pain Free
Yes
|
7 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Number of participants with absence of nausea, vomiting, photophobia and phonophobia.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Phonophobia
|
18 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Nausea
|
7 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Vomiting
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Photophobia
|
21 Participants
|
1 Participants
|
9 Participants
|
11 Participants
|
12 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Clinical disability for each participant was assessed using the Clinical Disability Questionnaire (CDQ). Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Disability
No disability
|
11 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Clinical Disability
Mild disability
|
10 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Clinical Disability
Moderate disability
|
14 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinical Disability
Severe disability
|
7 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
Use of rescue medication up to 24 hours after initiation of study drug.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Using Rescue Medication
|
69.0 Percentage of participants
|
25.0 Percentage of participants
|
91.7 Percentage of participants
|
58.3 Percentage of participants
|
53.6 Percentage of participants
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least one dose of study drug.
PGI scale is a participant-rated instrument that measures participants own global impression of their illness severity. Participants were asked to mark the box that best describes their headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received intravenous infusion of placebo solution.
|
Lasmiditan 2.5 mg
n=4 Participants
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 Participants
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 Participants
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 Participants
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 Participants
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 Participants
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
A little better
|
23.8 Percentage of Participants
|
0 Percentage of Participants
|
41.7 Percentage of Participants
|
29.2 Percentage of Participants
|
42.9 Percentage of Participants
|
18.8 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
No change
|
19.0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
29.2 Percentage of Participants
|
7.1 Percentage of Participants
|
12.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
A little worse
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
8.3 Percentage of Participants
|
4.2 Percentage of Participants
|
7.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Much worse
|
11.9 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Very much worse
|
2.4 Percentage of Participants
|
25.0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Very much better
|
9.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
8.3 Percentage of Participants
|
25.0 Percentage of Participants
|
37.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
Much better
|
19.0 Percentage of Participants
|
75.0 Percentage of Participants
|
8.3 Percentage of Participants
|
29.2 Percentage of Participants
|
17.9 Percentage of Participants
|
31.3 Percentage of Participants
|
50.0 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Lasmiditan 2.5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lasmiditan 5.0 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lasmiditan 10 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Lasmiditan 20 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Lasmiditan 30 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Lasmiditan 45 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Participants received intravenous injection of placebo solution.
|
Lasmiditan 2.5 mg
n=4 participants at risk
Participants received 2.5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 5.0 mg
n=12 participants at risk
Participants received 5 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 10 mg
n=24 participants at risk
Participants received 10 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 20 mg
n=28 participants at risk
Participants received 20 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 30 mg
n=16 participants at risk
Participants received 30 mg of lasmiditan administered as intravenous infusion.
|
Lasmiditan 45 mg
n=4 participants at risk
Participants received 45 mg of lasmiditan administered as intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
4.8%
2/42 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
2/16 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Visual impairment
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
2/42 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.7%
3/28 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
4.8%
2/42 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Discomfort
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.7%
3/28 • Number of events 4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
9.5%
4/42 • Number of events 4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
17.9%
5/28 • Number of events 6 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling abnormal
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling cold
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling hot
|
4.8%
2/42 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling of relaxation
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Infusion site paraesthesia
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
2/16 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Sensation of blood flow
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Swelling
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
2/42 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • Number of events 6 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
2/4 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
8/24 • Number of events 9 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
7/28 • Number of events 7 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Formication
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.8%
5/24 • Number of events 5 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
28.6%
8/28 • Number of events 11 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
3/16 • Number of events 4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Tension headache
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Phonophobia
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Tension
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
2.6%
1/38 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/10 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/21 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/14 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
1/16 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/42 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Vasoconstriction
|
2.4%
1/42 • Number of events 1 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/24 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/28 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/16 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up To 7 Days
All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
- Publication restrictions are in place
Restriction type: OTHER