Trial Outcomes & Findings for Lasmiditan Compared to Placebo in the Acute Treatment of Migraine: (NCT NCT02439320)

NCT ID: NCT02439320

Last Updated: 2019-12-16

Results Overview

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2231 participants
• Primary outcome timeframe: 2 hours post dose
• Results posted on: 2019-12-16

Participant Flow

Participants were randomized in a double-blind, placebo-controlled parallel group study.

Participant milestones

Measure	100 mg Lasmiditan 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
Overall Study STARTED	744	745	742
Overall Study Confirmed Eligibility	710	695	705
Overall Study 1st Dose (by 4 Hours Migraine Onset)	630	609	617
Overall Study 2nd Dose (After 2 Hour Assessment)	289	238	401
Overall Study COMPLETED	648	631	643
Overall Study NOT COMPLETED	96	114	99

Reasons for withdrawal

Measure	100 mg Lasmiditan 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.
Overall Study Adverse Event	0	2	0
Overall Study Lost to Follow-up	37	34	42
Overall Study Death	0	1	0
Overall Study Noncompliance with Protocol	10	11	7
Overall Study Pregnancy	0	1	1
Overall Study Withdrawal by Subject	12	16	14
Overall Study Physician Decision	2	1	0
Overall Study Sponsor Request	0	2	1
Overall Study Randomization Failure	35	46	34

Baseline Characteristics

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

Baseline characteristics by cohort

Measure	100 mg Lasmiditan n=630 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose	200 mg Lasmiditan n=609 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=617 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Total n=1856 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 11.67 • n=5 Participants	41.4 years STANDARD_DEVIATION 12.04 • n=7 Participants	42.4 years STANDARD_DEVIATION 12.30 • n=5 Participants	42.0 years STANDARD_DEVIATION 12.0 • n=4 Participants
Sex: Female, Male Female	512 Participants n=5 Participants	515 Participants n=7 Participants	525 Participants n=5 Participants	1552 Participants n=4 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	94 Participants n=7 Participants	92 Participants n=5 Participants	304 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	82 Participants n=5 Participants	77 Participants n=7 Participants	84 Participants n=5 Participants	243 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	544 Participants n=5 Participants	527 Participants n=7 Participants	529 Participants n=5 Participants	1600 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Black or African American	122 Participants n=5 Participants	125 Participants n=7 Participants	119 Participants n=5 Participants	366 Participants n=4 Participants
Race (NIH/OMB) White	471 Participants n=5 Participants	450 Participants n=7 Participants	479 Participants n=5 Participants	1400 Participants n=4 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment United States	630 Participants n=5 Participants	609 Participants n=7 Participants	617 Participants n=5 Participants	1856 Participants n=4 Participants
Duration of Migraine History	19.7 years STANDARD_DEVIATION 12.98 • n=5 Participants	18.9 years STANDARD_DEVIATION 13.12 • n=7 Participants	19.3 years STANDARD_DEVIATION 12.65 • n=5 Participants	19.3 years STANDARD_DEVIATION 12.92 • n=4 Participants

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

Outcome measures

Measure	100 mg Lasmiditan n=503 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=518 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=524 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Are Headache Pain Free	28.2 percentage of participants	32.2 percentage of participants	15.3 percentage of participants	—	—

PRIMARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable MBS data.

The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

Outcome measures

Measure	100 mg Lasmiditan n=469 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=481 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=488 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	40.9 percentage of participants	40.7 percentage of participants	29.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable headache relief data.

The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Have Headache Relief After First Dose	59.4 percentage of participants	59.5 percentage of participants	42.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: From 2 hours post dose up to 48 hours

Population: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants With Headache Recurrence	8.4 percentage of participants	10.1 percentage of participants	5.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 hours post dose

Population: 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 the migraine did not respond (participant was not pain free).

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Used Rescue Medication	26.2 percentage of participants	20.7 percentage of participants	46.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Anytime between 2-24 hours post dose

Population: 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 the migraine did not respond (participant was not pain free).

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=255 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Used Rescue Medication	8.9 percentage of participants	7.9 percentage of participants	11.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Anytime 24-48 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Who Used Rescue Medication	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

The percentage of participants without nausea.

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Nausea Free	64.6 percentage of participants	64.1 percentage of participants	62.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

The percentage of participants without phonophobia.

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Phonophobia Free	60.7 percentage of participants	58.7 percentage of participants	52.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.

The percentage of participants without photophobia.

Outcome measures

Measure	100 mg Lasmiditan n=562 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=555 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=554 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants Photophobia Free	53.9 percentage of participants	51.5 percentage of participants	38.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline up to 11 weeks

Population: All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.

Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section

Outcome measures

Measure	100 mg Lasmiditan n=630 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=609 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=617 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Participants With Serious Adverse Events (SAE)	0 Participants	2 Participants	1 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

Population: All randomized participants who used at least 1 dose of study drug, regardless of whether or not they underwent any study assessments.

Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

Outcome measures

Measure	100 mg Lasmiditan n=433 Participants 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan n=197 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	Placebo n=406 Participants Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	200 mg Lasmiditan/Placebo n=203 Participants 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.	Placebo/Placebo n=617 Participants Placebo tablets match each of the lasmiditan doses (100 mg and 200 mg) was administered orally, once for acute treatment of migraine. A second optional dose was administered between 2 and 24 hours for rescue or recurrence of migraine.
Percentage of Participants With Resource Utilization 6 Months prior to enrolling	4.4 percentage of participants	4.6 percentage of participants	3.0 percentage of participants	2.5 percentage of participants	2.8 percentage of participants
Percentage of Participants With Resource Utilization During time of study	0.9 percentage of participants	0.5 percentage of participants	0.2 percentage of participants	0.5 percentage of participants	0.6 percentage of participants

Adverse Events

100 mg Lasmiditan

Serious events: 0 serious events

Other events: 258 other events

Deaths: 0 deaths

200 mg Lasmiditan

Serious events: 2 serious events

Other events: 280 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 113 other events

Deaths: 0 deaths

Serious adverse events

Measure	100 mg Lasmiditan n=630 participants at risk Any participant who received 100 milligrams (mg) lasmiditan administered PO.	200 mg Lasmiditan n=609 participants at risk Any participant who received 200 milligrams (mg) lasmiditan administered PO.	Placebo n=617 participants at risk Any participant who received placebo administered PO.
General disorders Non-cardiac chest pain	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.

Other adverse events

Measure	100 mg Lasmiditan n=630 participants at risk Any participant who received 100 milligrams (mg) lasmiditan administered PO.	200 mg Lasmiditan n=609 participants at risk Any participant who received 200 milligrams (mg) lasmiditan administered PO.	Placebo n=617 participants at risk Any participant who received placebo administered PO.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.63% 4/630 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin sensitisation	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Vascular disorders Flushing	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.82% 5/609 • Number of events 5 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Vascular disorders Hot flush	0.79% 5/630 • Number of events 5 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Cardiac disorders Bradycardia	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Cardiac disorders Cardiac flutter	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Cardiac disorders Palpitations	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Ear and labyrinth disorders Hyperacusis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.95% 6/630 • Number of events 6 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Conjunctival hyperaemia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Glaucoma	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Mydriasis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Photophobia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Vision blurred	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.99% 6/609 • Number of events 6 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Eye disorders Visual impairment	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	1.3% 8/630 • Number of events 8 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.48% 3/630 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Hypoaesthesia oral	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Nausea	3.0% 19/630 • Number of events 19 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	5.4% 33/609 • Number of events 33 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	2.3% 14/617 • Number of events 16 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Toothache	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Vomiting	1.6% 10/630 • Number of events 10 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	1.1% 7/609 • Number of events 7 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.81% 5/617 • Number of events 5 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Abasia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Asthenia	0.95% 6/630 • Number of events 6 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	1.1% 7/609 • Number of events 7 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Chest discomfort	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Chills	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Fatigue	4.4% 28/630 • Number of events 28 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	3.4% 21/609 • Number of events 21 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling abnormal	1.1% 7/630 • Number of events 7 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling cold	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling drunk	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling hot	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling jittery	0.48% 3/630 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Feeling of relaxation	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Gait disturbance	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Malaise	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Pyrexia	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
General disorders Thirst	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Immune system disorders Hypersensitivity	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Breast cellulitis	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Candida infection	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Cystitis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Ear infection	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Gastroenteritis viral	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Influenza	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Otitis media	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Salmonellosis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Sinusitis	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.65% 4/617 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Viral infection	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Arthropod sting	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Exposure to toxic agent	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Laceration	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle strain	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Stress fracture	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Injury, poisoning and procedural complications Tooth fracture	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Investigations Blood pressure decreased	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Investigations Cardiac murmur	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Investigations Heart rate increased	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle twitching	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.82% 5/609 • Number of events 5 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	1.4% 9/630 • Number of events 9 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	1.6% 10/609 • Number of events 11 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Ataxia	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Aura	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Balance disorder	0.95% 6/630 • Number of events 6 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	1.1% 7/609 • Number of events 7 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Clumsiness	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Cognitive disorder	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Coordination abnormal	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Disturbance in attention	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Dizziness	13.8% 87/630 • Number of events 91 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	17.6% 107/609 • Number of events 114 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	3.6% 22/617 • Number of events 23 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Dysarthria	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Dyskinesia	0.63% 4/630 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Fine motor skill dysfunction	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Headache	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.32% 2/617 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Hyperaesthesia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Hypersomnia	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	1.4% 9/630 • Number of events 10 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	2.0% 12/609 • Number of events 13 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Hypotonia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Intracranial pressure increased	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Lethargy	2.4% 15/630 • Number of events 16 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	2.8% 17/609 • Number of events 18 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Mental impairment	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Migraine	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/617 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Paraesthesia	6.7% 42/630 • Number of events 43 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	8.2% 50/609 • Number of events 51 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	2.3% 14/617 • Number of events 14 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Parosmia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Presyncope	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Sedation	0.48% 3/630 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	1.3% 8/609 • Number of events 8 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Sensory disturbance	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Sensory integrative dysfunction	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Somnolence	6.3% 40/630 • Number of events 40 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	5.9% 36/609 • Number of events 37 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	2.3% 14/617 • Number of events 14 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Tremor	1.1% 7/630 • Number of events 7 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.66% 4/609 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Tunnel vision	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Nervous system disorders Visual field defect	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Abnormal dreams	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Affect lability	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Agitation	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Anxiety	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.82% 5/609 • Number of events 5 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Apathy	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Blunted affect	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Confusional state	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Depersonalisation	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Disorientation	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Dysphoria	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Euphoric mood	0.48% 3/630 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Hallucination, visual	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Hypnagogic hallucination	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Irritability	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Listless	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Nervousness	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Nightmare	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.49% 3/609 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Panic reaction	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Phonophobia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Restlessness	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.33% 2/609 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Psychiatric disorders Sleep disorder	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Renal and urinary disorders Micturition urgency	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.19% 1/525 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Reproductive system and breast disorders Breast mass	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.19% 1/525 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.32% 2/630 • Number of events 2 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.48% 3/630 • Number of events 3 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.63% 4/630 • Number of events 4 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Skin and subcutaneous tissue disorders Cold sweat	0.16% 1/630 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/609 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/617 • up to 11 weeks All randomized participants who had received at least one dose of study drug.
Vascular disorders Raynaud's phenomenon	0.00% 0/630 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.00% 0/609 • up to 11 weeks All randomized participants who had received at least one dose of study drug.	0.16% 1/617 • Number of events 1 • up to 11 weeks All randomized participants who had received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: Clinicaltrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60