A Study Lasmiditan (LY573144) in a Single Migraine Attack... | NCT03962738

ID	Type	Description	Link
H8H-JE-LAIH	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
50 milligram (mg) Lasmiditan	Experimental	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	Drug: Lasmiditan Drug: Placebo
100 mg Lasmiditan	Experimental	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	Drug: Lasmiditan Drug: Placebo
200 mg Lasmiditan	Experimental	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	Drug: Lasmiditan Drug: Placebo
Placebo	Placebo Comparator	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan	Drug	Administered orally	100 mg Lasmiditan 200 mg Lasmiditan 50 milligram (mg) Lasmiditan

Measure	Description	Time Frame
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)	Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.	2 Hours Postdose

Measure	Description	Time Frame
Percentage of Participants Who Are Headache Pain Free in Each Dose Group	Percentage of participants who are headache pain free in each dose group at 2 hours postdose.	2 Hours Postdose
Percentage of Participants With Headache Pain Relief

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Takanoko Hospital		Matsuyama	Ehime	790-0925	Japan
Ikeda Neurosurgical Clinic

PubMed Identifier	Type	Citation	Retractions
37255987	Derived	Kitamura S, Imai N, Tanji Y, Ozeki A, Komori M. Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study. J Pain Res. 2023 May 25;16:1725-1738. doi: 10.2147/JPR.S399567. eCollection 2023.
36136232	Derived

ID	Title	Description
FG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once to treat a single migraine attack.
FG001	50 Milligrams (mg) Lasmiditan

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 6, 2019	Feb 24, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)

Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.

All randomized participants who received at least one dose of study drug to treat a migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Units	Counts
Participants	OG000211 OG001179

Title

Denominators

Categories

Title	Measurements
	OG00016.6 OG00140.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		<0.001		Odds Ratio (OR)	3.46			2-Sided	95	2.17	5.54					Superiority

Secondary

Percentage of Participants Who Are Headache Pain Free in Each Dose Group

Percentage of participants who are headache pain free in each dose group at 2 hours postdose.

All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With Headache Pain Relief

Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.

All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan

Secondary

Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine

Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose.

Missing value at a particular time point was considered as "nonresponder."

All randomized participants who received at least one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments. Participants with no symptoms at pre-dose were excluded from the analysis.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With 24-Hour Sustained Pain Freedom

Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

24 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With 48-Hour Sustained Pain Freedom

Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

48 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants That Are Free of Phonophobia

Percentage of participants that are free of phonophobia at 2 hours postdose.

All randomized participants who received at least one dose of drug and had any postdose headache severity or symptom assessment.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants That Are Free of Photophobia

Percentage of participants that are free of photophobia at 2 hours postdose.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants That Are Free of Nausea

Percentage of participants that are free of nausea at 2 hours postdose.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablet (plus matching Lasmiditan placebo to maintain the blind) administered orally once to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet (plus two placebo tablets to maintain the blind) administered orally once to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet (plus two placebo tablets to maintain the blind) administered orally once to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to maintain the blind) administered orally once to treat a single migraine attack.

Secondary

Percentage of Participants That Are Free of Vomiting

Percentage of participants that are free of vomiting at 2 hours postdose.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With Pain Freedom

Percentage of participants with pain freedom.

All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

1 Hour Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With Headache Pain Relief

Percentage of participants with headache pain relief at 1 hour postdose.

All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

1 Hour Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)

Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.

All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

1 Hour Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG003	200 mg Lasmiditan

Secondary

Percentage of Participants With No Disability

Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.

Percentage of participants who are responders defined as score = 0 at 1 hours postdose.

All randomized participants who received one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.

Posted

Number

percentage of participants

1 Hour Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Percentage of Participants With No Disability

Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0.

Percentage of participants who are responders defined as score = 0 at 2 hours postdose.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan

The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 24 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..

Secondary

Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale

The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 24 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..
OG003

Secondary

Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)

The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Number

percentage of participants

2 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack..
OG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Secondary

Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)

The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.

All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.

Posted

Mean

Standard Deviation

score on a scale

24 Hours Postdose

ID	Title	Description
OG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
OG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
OG002	100 mg Lasmiditan

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0014 events4 affected87 at risk EG00210 events9 affected208 at risk EG0034 events4 affected182 at risk
Hyperacusis	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0014 events4 affected87 at risk EG0025 events5 affected208 at risk EG003
Blepharospasm	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Eye pruritus	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Photophobia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Photopsia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Scintillating scotoma	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Vision blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Visual impairment	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Xanthopsia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected87 at risk EG0022 events2 affected208 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected214 at risk EG0011 events1 affected87 at risk EG0027 events7 affected208 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected214 at risk EG0013 events3 affected87 at risk EG00211 events11 affected208 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected214 at risk EG0011 events1 affected87 at risk EG0026 events5 affected208 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0015 events5 affected87 at risk EG00214 events14 affected208 at risk EG003
Chest discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Chills	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0024 events4 affected208 at risk EG003
Discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0022 events2 affected208 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0011 events1 affected87 at risk EG0025 events5 affected208 at risk EG003
Feeling abnormal	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0027 events7 affected208 at risk EG003
Feeling hot	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0021 events1 affected208 at risk EG003
Gait disturbance	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected214 at risk EG0016 events6 affected87 at risk EG00224 events23 affected208 at risk EG003
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Thirst	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0012 events2 affected87 at risk EG0020 events0 affected208 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Body temperature increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0022 events2 affected208 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0022 events2 affected208 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG00211 events11 affected208 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0021 events1 affected208 at risk EG003
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected214 at risk EG00118 events18 affected87 at risk EG00280 events79 affected208 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events2 affected87 at risk EG0022 events2 affected208 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Head discomfort	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG00212 events12 affected208 at risk EG003
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Sensory disturbance	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Sleep paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected214 at risk EG0017 events7 affected87 at risk EG00245 events44 affected208 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Tension headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0022 events2 affected208 at risk EG003
Dissociative disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Euphoric mood	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Irritability	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0012 events1 affected87 at risk EG0023 events2 affected208 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected178 at risk EG0010 events0 affected75 at risk EG0021 events1 affected176 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected178 at risk EG0010 events0 affected75 at risk EG0020 events0 affected176 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected178 at risk EG0010 events0 affected75 at risk EG0021 events1 affected176 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Yawning	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0011 events1 affected87 at risk EG0020 events0 affected208 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Hot flush	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected214 at risk EG0010 events0 affected87 at risk EG0020 events0 affected208 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected214 at risk EG0010 events0 affected87 at risk EG0021 events1 affected208 at risk EG003

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Title	Description
BG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
BG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
BG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
BG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.	214	214	50	214
EG001	50 mg Lasmiditan	50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	87	87	44	87
EG002	100 mg Lasmiditan	100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	208	208	147	208
EG003	200 mg Lasmiditan	200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.	182	182	147	182