Trial Outcomes & Findings for Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment (NCT NCT00883051)
NCT ID: NCT00883051
Last Updated: 2019-12-23
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 administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
512 participants
Primary outcome timeframe
2 hours postdose
Results posted on
2019-12-23
Participant Flow
Participant milestones
| Measure |
50 mg Lasmiditan
50 mg lasmiditan administered PO within 4 hours of a migraine attack
|
100 mg Lasmiditan
100 mg lasmiditan administered PO within 4 hours of a migraine attack
|
200 mg Lasmiditan
200 mg lasmiditan administered PO within 4 hours of a migraine attack
|
400 mg Lasmiditan
400 mg lasmiditan administered PO within 4 hours of a migraine attack
|
Placebo
Placebo administered PO within 4 hours of a migraine attack
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
104
|
100
|
99
|
103
|
|
Overall Study
No Study Medication Used
|
24
|
22
|
29
|
29
|
17
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
82
|
82
|
71
|
70
|
86
|
|
Overall Study
COMPLETED
|
82
|
82
|
71
|
70
|
85
|
|
Overall Study
NOT COMPLETED
|
24
|
22
|
29
|
29
|
18
|
Reasons for withdrawal
| Measure |
50 mg Lasmiditan
50 mg lasmiditan administered PO within 4 hours of a migraine attack
|
100 mg Lasmiditan
100 mg lasmiditan administered PO within 4 hours of a migraine attack
|
200 mg Lasmiditan
200 mg lasmiditan administered PO within 4 hours of a migraine attack
|
400 mg Lasmiditan
400 mg lasmiditan administered PO within 4 hours of a migraine attack
|
Placebo
Placebo administered PO within 4 hours of a migraine attack
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Did not use study medication
|
24
|
22
|
29
|
29
|
17
|
Baseline Characteristics
Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment
Baseline characteristics by cohort
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered PO within 4 hours of a migraine attack
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered PO within 4 hours of a migraine attack
|
200 mg Lasmiditan
n=71 Participants
200 mg lasmiditan administered PO within 4 hours of a migraine attack
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered PO within 4 hours of a migraine attack
|
Placebo
n=86 Participants
Placebo administered PO within 4 hours of a migraine attack
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
n=93 Participants
|
45 years
n=4 Participants
|
41 years
n=27 Participants
|
40 years
n=483 Participants
|
41 years
n=36 Participants
|
41.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
342 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
49 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
390 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
86 Participants
n=36 Participants
|
387 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
4 participants
n=483 Participants
|
7 participants
n=36 Participants
|
27 participants
n=10 Participants
|
|
Region of Enrollment
Finland
|
26 participants
n=93 Participants
|
26 participants
n=4 Participants
|
23 participants
n=27 Participants
|
19 participants
n=483 Participants
|
30 participants
n=36 Participants
|
124 participants
n=10 Participants
|
|
Region of Enrollment
France
|
9 participants
n=93 Participants
|
8 participants
n=4 Participants
|
5 participants
n=27 Participants
|
5 participants
n=483 Participants
|
9 participants
n=36 Participants
|
36 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=93 Participants
|
34 participants
n=4 Participants
|
34 participants
n=27 Participants
|
37 participants
n=483 Participants
|
32 participants
n=36 Participants
|
173 participants
n=10 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=93 Participants
|
9 participants
n=4 Participants
|
3 participants
n=27 Participants
|
5 participants
n=483 Participants
|
8 participants
n=36 Participants
|
31 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 2 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had a post-baseline evaluation.
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 administration of study drug.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=81 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=69 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=68 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Headache Response
No
|
57.0 percentage of participants
|
35.8 percentage of participants
|
49.3 percentage of participants
|
35.3 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants With Headache Response
Yes
|
43.0 percentage of participants
|
64.2 percentage of participants
|
50.7 percentage of participants
|
64.7 percentage of participants
|
25.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: All randomized participants who received at least 1 dose of study drug, a 2 hour postdose evaluation and evaluable headache relief data.
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=81 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=69 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=68 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Are Headache Free (Absence of Headache) After First Dose
|
13.9 percentage of participants
|
13.6 percentage of participants
|
18.8 percentage of participants
|
27.9 percentage of participants
|
7.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 hours postdosePopulation: Randomized participants who received a dose of study drug, were pain free at 2 hours postdose and had postdose headache severity or symptom assessments.
Participants who received study drug and which became pain free at 2 hours postdose and worsened again upto 24 hours post-dose.
Outcome measures
| Measure |
50 mg Lasmiditan
n=34 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=35 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=44 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=21 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Headache Recurrence
|
55.9 percentage of participants
|
57.7 percentage of participants
|
62.9 percentage of participants
|
50.0 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Headache severity was evaluated by the participant using the International Headache Society (IHS) four point headache severity rating scale (0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) with a lower score being less severe and a higher score being more severe.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=80 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=68 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Headache Severity (4 Point Rating Scale)
None (0)
|
13.9 percentage of participants
|
13.6 percentage of participants
|
18.8 percentage of participants
|
27.9 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Mild(1)
|
29.1 percentage of participants
|
50.6 percentage of participants
|
31.9 percentage of participants
|
36.8 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Moderate(2)
|
27.8 percentage of participants
|
23.5 percentage of participants
|
26.1 percentage of participants
|
20.6 percentage of participants
|
27.2 percentage of participants
|
|
Percentage of Participants With Headache Severity (4 Point Rating Scale)
Severe(3)
|
29.1 percentage of participants
|
11.1 percentage of participants
|
21.7 percentage of participants
|
13.2 percentage of participants
|
46.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Randomized participants who received a dose of study drug and had postdose symptom assessments.
Percentage of participants who have symptoms of nausea two hours post treatment.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=80 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=68 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Have Symptoms of Nausea
|
31.65 percentage of participants
|
25.00 percentage of participants
|
35.29 percentage of participants
|
26.87 percentage of participants
|
40.74 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Randomized participants who received a dose of study drug and had postdose symptom assessments.
Percentage of participants who have symptoms of phonophobia two hours post treatment.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=80 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=68 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Have Symptoms Phonophobia
|
41.77 percentage of participants
|
23.75 percentage of participants
|
39.71 percentage of participants
|
31.34 percentage of participants
|
48.15 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Randomized participants who received a dose of study drug and had postdose symptom assessments.
Percentage of participants who have symptoms of photophobia two hours post treatment.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=80 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=68 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Have Photophobia
|
46.84 percentage of participants
|
31.25 percentage of participants
|
41.18 percentage of participants
|
37.31 percentage of participants
|
65.43 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: Randomized participants who received a dose of study drug and had postdose symptom assessments.
Percentage of participants with vomiting 2 hours post treatment.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=80 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=68 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Vomiting
|
5.06 percentage of participants
|
0.00 percentage of participants
|
7.35 percentage of participants
|
4.80 percentage of participants
|
11.11 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
The participant is asked "How much is the migraine interfering with normal activities?" on a 4 point scale 0-Not at all, 1-Mild interference, 2-Marked interference ,3-Completely needs bed rest, with a lower score having lower interference and higher score worse interference.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=78 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=66 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=63 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
Mild interference (1)
|
26 Participants
|
33 Participants
|
23 Participants
|
26 Participants
|
23 Participants
|
|
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
Marked interference (2)
|
24 Participants
|
20 Participants
|
17 Participants
|
15 Participants
|
21 Participants
|
|
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
Completely needs bed rest (3)
|
16 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
31 Participants
|
|
Disability (4 Point Scale: Not at All, Mild Interference, Marked Interference, Completely - Needs Bed Rest)
Not at all (0)
|
13 Participants
|
14 Participants
|
12 Participants
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Postdose 2 through 24 hoursPopulation: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.
Rescue medication was permitted after completion of the 2 hour assessment if migraine did not respond (participant was not pain free).
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=81 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=69 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=69 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Used Rescue Medication
|
54.5 percentage of participants
|
51.9 percentage of participants
|
61.2 percentage of participants
|
41.8 percentage of participants
|
68.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had a PGI-I measurement post dose.
PGI-I requests participants to mark the box that best describes their cluster 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, a lower number indicates much better and a higher number indicates worse.
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=81 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=69 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=67 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
Very much better
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
A little better
|
28 Participants
|
30 Participants
|
21 Participants
|
22 Participants
|
18 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
No change
|
18 Participants
|
11 Participants
|
12 Participants
|
7 Participants
|
27 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
A little worse
|
7 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
Much worse
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
Very much worse
|
3 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Reporting a Score on the Patient Global Impression of Improvement (PGI-I)
Much better
|
15 Participants
|
27 Participants
|
16 Participants
|
19 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 24 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug.
The participant answered "Did your migraine pain go away completely (pain free) within 24 hours of dosing" and record the time. Actual time to meaningful pain relief and actual time to pain free will be censored at 24 hours if meaningful pain relief or pain free is documented to be greater than 24 hours after dosing and "Did you experience meaningful relief (headache relief) from your migraine within 24 hours after dosing?".
Outcome measures
| Measure |
50 mg Lasmiditan
n=79 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=81 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=69 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=68 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=81 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Actual Time to Headache Relief and Time to Pain Free
Pain relief
|
650.87 minutes
Standard Error 77.53
|
291.05 minutes
Standard Error 32.24
|
407.16 minutes
Standard Error 52.48
|
218.93 minutes
Standard Error 23.87
|
760.15 minutes
Standard Error 71.19
|
|
Actual Time to Headache Relief and Time to Pain Free
Pain free
|
871.27 minutes
Standard Error 72.74
|
767.33 minutes
Standard Error 74.36
|
690.89 minutes
Standard Error 59.67
|
437.12 minutes
Standard Error 36.05
|
1046.47 minutes
Standard Error 77.90
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: Randomized participants who received at least 1 dose of study drug and had evaluable ECG parameters.
Change from baseline in assessment of vital signs (heart rate).
Outcome measures
| Measure |
50 mg Lasmiditan
n=81 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=83 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate
|
2.0 beats per minute
Interval -27.0 to 28.0
|
3.0 beats per minute
Interval -16.0 to 24.0
|
1.0 beats per minute
Interval -18.0 to 28.0
|
2.0 beats per minute
Interval -21.0 to 28.0
|
1.0 beats per minute
Interval -66.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: All randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Change from baseline in vital signs (systolic blood pressure).
Outcome measures
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=70 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=83 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
|
1.0 millimeters of mercury
Interval -30.0 to 29.0
|
0.0 millimeters of mercury
Interval -25.0 to 42.0
|
-1.5 millimeters of mercury
Interval -23.0 to 35.0
|
-0.5 millimeters of mercury
Interval -35.0 to 36.0
|
-0.0 millimeters of mercury
Interval -30.0 to 35.0
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: Randomized participants who received at least 1 dose of study drug and had evaluable blood pressure.
Change from baseline in vital signs (diastolic blood pressure).
Outcome measures
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=70 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=83 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
|
0.0 millimeters of mercury
Interval -14.0 to 21.0
|
0.0 millimeters of mercury
Interval -20.0 to 25.0
|
0.0 millimeters of mercury
Interval -22.0 to 15.0
|
0.0 millimeters of mercury
Interval -20.0 to 20.0
|
0.0 millimeters of mercury
Interval -20.0 to 21.0
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: All randomized participants who received at last 1 dose of study drug and had a physical examination.
Participants were evaluated for skin, head, ear, nose and throat, cardiovascular and musculoskeletal changes from a normal screening to an abnormal screening. Changes in the physical examination noted as non-serious AEs or SAEs, regardless of causality, are located in the Reported Adverse Events section.
Outcome measures
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=86 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Skin
|
1.2 percentage of participants
|
2.4 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Head, ears, nose, throat
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Physical Examination Parameters
Musculoskeletal
|
0 percentage of participants
|
1.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Day 14Population: All randomized participants who received at least 1 dose of study drug and had evaluable blood parameters.
Hematology tests, including a complete blood count (CBC) measured red blood cells, white blood cells, hemoglobin, neutrophils and platelets.
Outcome measures
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=84 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Tests
Hemoglobin
|
0.0 million cells per liter
Standard Error 0.4
|
0.0 million cells per liter
Standard Error 0.4
|
0.1 million cells per liter
Standard Error 0.4
|
0.0 million cells per liter
Standard Error 0.4
|
0.0 million cells per liter
Standard Error 0.4
|
|
Change From Baseline in Hematology Tests
Red blood cells
|
0.0 million cells per liter
Standard Error 0.2
|
0.0 million cells per liter
Standard Error 0.2
|
0.0 million cells per liter
Standard Error 0.2
|
0.0 million cells per liter
Standard Error 0.2
|
0.0 million cells per liter
Standard Error 0.2
|
|
Change From Baseline in Hematology Tests
White blood cells
|
-0.1 million cells per liter
Standard Error 1.3
|
0.3 million cells per liter
Standard Error 1.4
|
-0.3 million cells per liter
Standard Error 1.6
|
-0.4 million cells per liter
Standard Error 1.7
|
-0.2 million cells per liter
Standard Error 1.6
|
|
Change From Baseline in Hematology Tests
Neutrophils
|
-3.2 million cells per liter
Standard Error 9.3
|
-0.3 million cells per liter
Standard Error 7.9
|
-2.8 million cells per liter
Standard Error 14.7
|
-3.2 million cells per liter
Standard Error 14.7
|
-3.9 million cells per liter
Standard Error 9.9
|
|
Change From Baseline in Hematology Tests
Platelets
|
-2.3 million cells per liter
Standard Error 35.2
|
-0.5 million cells per liter
Standard Error 25.9
|
4.6 million cells per liter
Standard Error 48.4
|
2.9 million cells per liter
Standard Error 34.7
|
1.7 million cells per liter
Standard Error 34.7
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: All randomized participants who received at least 1 dose of study drug excluding one participant who was lost to follow-up and did not report adverse events.
A summary of non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
50 mg Lasmiditan
n=82 Participants
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 Participants
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 Participants
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 Participants
400 mg lasmiditan administered orally (PO)
|
Placebo
n=85 Participants
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Number of Serious Adverse Events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
Adverse Events
50 mg Lasmiditan
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
100 mg Lasmiditan
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
200 mg Lasmiditan
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
400 mg Lasmiditan
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
50 mg Lasmiditan
n=82 participants at risk
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 participants at risk
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 participants at risk
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 participants at risk
400 mg lasmiditan administered orally (PO)
|
Placebo
n=85 participants at risk
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
Other adverse events
| Measure |
50 mg Lasmiditan
n=82 participants at risk
50 mg lasmiditan administered orally (PO)
|
100 mg Lasmiditan
n=82 participants at risk
100 mg lasmiditan administered orally (PO)
|
200 mg Lasmiditan
n=71 participants at risk
200 mg lasmiditan administered orally (PO)
|
400 mg Lasmiditan
n=70 participants at risk
400 mg lasmiditan administered orally (PO)
|
Placebo
n=85 participants at risk
Placebo administered orally (PO)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/85 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Cardiac disorders
Cardiovascular disorder
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Cardiac disorders
Extrasystoles
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Cardiac disorders
Palpitations
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.3%
3/70 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Ear and labyrinth disorders
Vertigo
|
9.8%
8/82 • Number of events 8 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
14.6%
12/82 • Number of events 12 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
16.9%
12/71 • Number of events 12 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
22.9%
16/70 • Number of events 16 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Eye disorders
Diplopia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Eye disorders
Halo vision
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Eye disorders
Vision blurred
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.2%
3/71 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Eye disorders
Visual impairment
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.3%
3/70 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.2%
1/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
4/82 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
9.8%
8/82 • Number of events 8 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
7.1%
5/70 • Number of events 6 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
3/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Asthenia
|
3.7%
3/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
8.5%
7/82 • Number of events 7 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
5.7%
4/70 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Chest discomfort
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Chills
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Discomfort
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
5.6%
4/71 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
5.7%
4/70 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/85 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Fatigue
|
12.2%
10/82 • Number of events 11 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
20.7%
17/82 • Number of events 17 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
21.1%
15/71 • Number of events 15 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
22.9%
16/70 • Number of events 16 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/85 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Feeling abnormal
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Feeling cold
|
3.7%
3/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.9%
4/82 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Feeling hot
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Feeling of relaxation
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Gait disturbance
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Malaise
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Pyrexia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Sensation of blood flow
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
General disorders
Thirst
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Investigations
Blood pressure increased
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Investigations
Cardiac murmur
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Investigations
Transaminases increased
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.2%
3/71 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.7%
3/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
6.1%
5/82 • Number of events 5 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
5.6%
4/71 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.3%
3/70 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.2%
1/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Ataxia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Balance disorder
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.2%
3/71 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Disturbance in attention
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
3.7%
3/82 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Dizziness
|
23.2%
19/82 • Number of events 21 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
25.6%
21/82 • Number of events 22 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
36.6%
26/71 • Number of events 26 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
37.1%
26/70 • Number of events 27 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Dysaesthesia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Fine motor delay
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Headache
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Hyperkinesia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
3.7%
3/82 • Number of events 4 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
7.0%
5/71 • Number of events 5 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
5.7%
4/70 • Number of events 5 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Hypotonia
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.8%
2/71 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Migraine
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
11.0%
9/82 • Number of events 9 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
16.9%
12/71 • Number of events 16 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
20.0%
14/70 • Number of events 14 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/85 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Sedation
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Slow response to stimuli
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Somnolence
|
9.8%
8/82 • Number of events 8 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
12.2%
10/82 • Number of events 11 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
11.3%
8/71 • Number of events 9 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
11.4%
8/70 • Number of events 8 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/85 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.3%
3/70 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Nervous system disorders
Tremor
|
3.7%
3/82 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
4.3%
3/70 • Number of events 3 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Derealisation
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Euphoric mood
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Fear
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Illusion
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Nightmare
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/85 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Psychiatric disorders
Restlessness
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/70 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Renal and urinary disorders
Polyuria
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.9%
2/70 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/82 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Vascular disorders
Flushing
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
2.4%
2/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.4%
1/71 • Number of events 1 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/82 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
1.2%
1/82 • Number of events 2 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/71 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/70 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
0.00%
0/85 • up to 8 weeks
All randomized participants who received at least 1 dose of study drug excluding one participant from the placebo group who did not report adverse events and was lost to follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60