A Study of Lasmiditan (LY573144) Over Four Migraine Attacks | NCT03670810 | Trialant
NCT03670810
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 29, 2022Actual
Enrollment
1,633Actual
Phase
Phase 3
Conditions
Migraine
Interventions
Lasmiditan
Placebo
Countries
United States
Austria
Belgium
China
Czechia
Denmark
France
Germany
Hungary
India
Italy
Mexico
Netherlands
Russia
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03670810
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17131
Secondary IDs
ID
Type
Description
Link
H8H-MC-LAIJ
Other Identifier
Eli Lilly and Company
2018-001661-17
EudraCT Number
Brief Title
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Official Title
Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 24, 2019Actual
Primary Completion Date
Jun 12, 2020Actual
Completion Date
Jul 8, 2021Actual
First Submitted Date
Sep 12, 2018
First Submission Date that Met QC Criteria
Sep 12, 2018
First Posted Date
Sep 14, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 11, 2021
Results First Submitted that Met QC Criteria
Jun 11, 2021
Results First Posted Date
Jul 2, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 29, 2022
Last Update Posted Date
Jul 29, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.
Detailed Description
Not provided
Conditions Module
Conditions
Migraine
Keywords
acute treatment
migraine pain
multiple attacks
headache
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,633Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
100 milligram (mg) Lasmiditan
Experimental
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
200 mg Lasmiditan
Experimental
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
Control 1 Sequence
Placebo Comparator
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
Control 2 Sequence
Placebo Comparator
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lasmiditan
Drug
Administered orally.
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
100 milligram (mg) Lasmiditan
200 mg Lasmiditan
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
2 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
2 Hours Postdose
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time.
2 Hours Postdose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
History of disabling migraine for at least 1 year
Migraine onset before the age of 50 years
History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
MIDAS score ≥11
Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
Women of child-bearing potential must be using or willing to use a highly effective form of contraception
Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed
Exclusion Criteria:
Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
History of orthostatic hypotension with syncope
Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
Use of more than 3 doses per month of either opioids or barbiturates
Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
Pregnant or breast-feeding women
History of drug or alcohol abuse/dependence within 1 year prior to screening
Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
Currently enrolled in any other clinical study involving an investigational product
Relatives of, or staff directly reporting to, the Investigator
Participants who are employees of the sponsor
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
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)
Komori M, Ozeki A, Tanji Y, Kamiki E, Krege JH, Li LQ, Suzuki S, Shibata M, Takeshima T. Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial. J Headache Pain. 2024 Mar 25;25(1):43. doi: 10.1186/s10194-024-01745-y.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
An ITT evaluable attack is defined as a treated attack of least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose.
Recruitment Details
Participants were considered study completers after treating 4 migraine attacks or after completing 4 months of study duration regardless of number of treated attacks in the main study. Participants may continue in Open-Label Extension (OLE) if they met OLE eligibility criteria.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
100 Milligram (mg) Lasmiditan
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG001
Periods
Title
Milestones
Reasons Not Completed
Main Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 30, 2020
Jun 10, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Lasmiditan
Drug: Placebo
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
Experimental
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
200 mg Lasmiditan MEE
Experimental
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
Control 1 Sequence MEE
Placebo Comparator
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
Control 2 Sequence MEE
Placebo Comparator
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Drug: Lasmiditan
Drug: Placebo
Open Label Extension
Experimental
Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
Drug: Lasmiditan
200 mg Lasmiditan MEE
Control 1 Sequence
Control 1 Sequence MEE
Control 2 Sequence
Control 2 Sequence MEE
Open Label Extension
LY573144
Placebo
Drug
Administered orally.
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
100 milligram (mg) Lasmiditan
200 mg Lasmiditan
200 mg Lasmiditan MEE
Control 1 Sequence
Control 1 Sequence MEE
Control 2 Sequence
Control 2 Sequence MEE
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks
Headache pain relief is defined as a reduction in pain severity from moderate to severe at baseline to mild or none at 2 hours postdose in at least 2 out of 3 attacks. To evaluate at least 2 out of 3 consistency endpoints, the results of ITT-evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT-evaluable attacks, only the first 3 with the same treatment will be considered.
2 Hours Postdose
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack
Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.
24 Hours
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack
Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.
48 Hours Postdose
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack. A triptan insufficient responder is defined as having one of the following: 1) Scoring ≤5 on 4 questions from the Migraine Treatment Optimization Questionnaire (mTOQ-6) that defines participants with poor or very poor response to their current regimen; 2) Indicated they obtained pain freedom at 2 hours in 0 out of 3, or 1 out of 3 attacks when treated with the most recent triptan, or 3) are not currently taking triptan and discontinued their most recent triptan due to lack of efficacy, tolerability issue, or contradictions to a past triptan.
2 Hours Postdose
Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack
Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack. Disability was measured by determining the level of interference with normal activities with 4 response options including not at all; mild interference, marked interference; and need complete bed rest.
2 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at the indicated assessment time. A subject is not counted as being pain-free at a specific time point if she or he used rescue or recurrence medication at or before the specific time point.
2 Hours Postdose
Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack
MBS freedom is defined as the absence of the associated symptom of migraine (nausea, phonophobia, or photophobia) at the indicated assessment time that was identified at baseline as the most bothersome symptom.
2 Hours Postdose
Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack
Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack
24 Hours
Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack
Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.
2 Hours Postdose
Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack
Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in participants who were pain free at 2 hours.
24 Hours
Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack
Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.
30 Minutes (Min) and 1 Hour (Hr) Postdose
Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that reflect the number of days reported as missed, or with reduced productivity at work or home and social events. Each question is answered as the number of days during the past 3 months of assessment, ranging from 0 to 90, with the total score being the summation of the 5 numeric responses. A higher value is indicative of more disability.
Baseline, Week 16
Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack
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. Reported are participants whose combined impression of change since taking the medicine was very much better and much better at 2 hours postdose.
2 Hours Postdose
Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack
The 24-hour Migraine Quality of Life Questionnaire (24-hr MQoLQ) has been specifically developed to measure the HRQoL of participants with migraine within a 24-hour period after having taken migraine medication A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, with lower scores indicating less impairment. The questionnaire will be administered 24 hours after dosing with study drug during each migraine. The analysis of variance (ANOVA) model was used with region and treatment adjusted for the overall treatment effect.
24 Hours Post First Dose
Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire
Treatment satisfaction was evaluated at the End of Study (EoS) visit by determining the participant's level of satisfaction (ranging from extremely dissatisfied to extremely satisfied); their willingness to take this treatment again (ranging from strongly disagree to strongly agree) and if they would they recommend this treatment to another participants (ranging from strongly disagree to strongly agree).
Week 16
Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack
The EQ-5D-5L questionnaire is a participant-rated scale that assesses health status, it consists of 2 parts. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 possible levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems).The EQ-5D can be used to generate a health state index score, which is used to compute quality-adjusted life years for utilization in health economic analyses. The health state index score is 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) to 1 (perfect health), with higher scores indicating better health utility. ANCOVA was used to assess the effect of Lasmiditan over placebo or control. The model includes fixed categorical effect of treatment and geographic region and baseline as covariate.
Baseline, 24 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe to none at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
2 Hours Postdose
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
2 Hours Postdose
Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack
Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.
2 Hours Postdose
Phoenix
Arizona
85013
United States
UCSD Altman Clinical & Translational Research Institute (ACTRI)
La Jolla
California
92121
United States
Colorado Neurological Institute
Englewood
Colorado
80113
United States
Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
George Washington University Medical Center
Washington D.C.
District of Columbia
20037
United States
Diamond Headache Clinic
Chicago
Illinois
60642
United States
Ochsner Medical Center - North Shore
Covington
Louisiana
70433
United States
StudyMetrix Research, LLC
City of Saint Peters
Missouri
63303
United States
Nevada Headache Institute
Las Vegas
Nevada
89113-2237
United States
Dent Neurological Institute
Amherst
New York
14226
United States
Island Neuro Associates,PC
Plainview
New York
11803
United States
Montefiore Headache Center
The Bronx
New York
10461
United States
Northwest Clinical Research Center
Bellevue
Washington
98007-4209
United States
Universitätsklinik Innsbruck
Innsbruck
Tyrol
6020
Austria
KH der Barmherzigen Schwestern Linz BetriebsGesmbH
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango
34000
Mexico
Eci Estudios Clinicos Int.
Puebla City
72160
Mexico
Centro de Atención e Investigación Cardiovascular del Potosà S.C.
San Luis Potosà City
78200
Mexico
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Gelderland
6532 SZ
Netherlands
Boerhaave Medisch Centrum
Amsterdam
1078 VV
Netherlands
Isala Klinieken
Zwolle
8025 AB
Netherlands
First Moscow State Medical University n.a. Sechenov
Moscow
119991
Russia
University Headache Clinic
Moscow
121467
Russia
Medis Priokskiy
Nizhny Novgorod
603137
Russia
Saint Petersburg State Medical University n.a. Pavlov I.P.
Saint Petersburg
197022
Russia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Hospital Universitario Marques De Valdecilla
Santander
Cantabria
39008
Spain
Clinica Universitaria De Navarra
Pamplona
Navarre
31008
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
Hospital Universitario Virgen del Rocio
Seville
41013
Spain
Hospital ClÃnico Universitario de Valencia
Valencia
46010
Spain
Hospital Universitario La Fe de Valencia
Valencia
46026
Spain
Hospital Clinico Universitario de Valladolid
Valladolid
47010
Spain
H.C.U. Lozano Blesa
Zaragoza
50009
Spain
Kantonsspital Luzern
Lucerne
Canton of Lucerne
6000
Switzerland
Kantonsspital St. Gallen
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
KopfwehZentrum Hirslanden Zürich
Zollikon
Canton of Zurich
8702
Switzerland
Rehaclinic Bad Zurzach
Bad Zurzach
5330
Switzerland
Inselspital Bern
Bern
3010
Switzerland
Synexus Thames Valley Clinical Research Centre
Reading
Berkshire
RG2 0TG
United Kingdom
Hull Royal Infirmary
Hull
East Yorkshire
HU3 2JZ
United Kingdom
Kings College Hospital
London
Greater London
SE5 9RS
United Kingdom
Re-Cognition Health Ltd
London
Greater London
W1G 9JF
United Kingdom
Synexus Manchester Clinical Research Centre
Manchester
Greater Manchester
M15 6SX
United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley
Lancashire
PR7 7NA
United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool
Merseyside
L22 0LG
United Kingdom
Synexus Hexham General Hospital
Hexham
Northumberland
NE46 1QJ
United Kingdom
Queen Elizabeth University Hospital
Glasgow
Scotland
G51 4TF
United Kingdom
Synexus Wales Clinical Research Centre
Cardiff
South Glamorgan
CF15 9SS
United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow
Strathclyde
G20 0SP
United Kingdom
Re-Cognition Health Ltd
Guildford
Surrey
GU2 7YD
United Kingdom
Re-Cognition Health Ltd
Birmingham
West Midlands
B16 8LT
United Kingdom
Synexus Midlands Clinical Research Center
Birmingham
Wstmid
B15 2SQ
United Kingdom
Derived
Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.
Ashina M, Roos C, Li LQ, Komori M, Ayer D, Ruff D, Krege JH. Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial. Cephalalgia. 2023 Apr;43(4):3331024231161745. doi: 10.1177/03331024231161745.
Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.
MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.
Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.
Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG002
Control 1 Sequence
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG003
Control 2 Sequence
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG004
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG005
200 mg Lasmiditan MEE
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG006
Control 1 Sequence MEE
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG007
Control 2 Sequence MEE
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
FG008
Open-Label Extension
Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
FG000485 subjects
FG001486 subjects
FG002249 subjects
FG003251 subjects
FG00455 subjects
FG00553 subjects
FG00628 subjects
FG00726 subjects
FG0080 subjects
Treated at Least One Migraine Attack
FG000485 subjects
FG001486 subjects
FG002249 subjects
FG003251 subjects
FG00455 subjects
FG00553 subjects
FG00628 subjects
FG00726 subjects
FG0080 subjects
COMPLETED
FG000403 subjects
FG001394 subjects
FG002219 subjects
FG003223 subjects
FG00445 subjects
FG00546 subjects
FG00626 subjects
FG00723 subjects
FG0080 subjects
NOT COMPLETED
FG00082 subjects
FG00192 subjects
FG00230 subjects
FG00328 subjects
FG00410 subjects
FG0057 subjects
FG0062 subjects
FG0073 subjects
FG0080 subjects
Type
Comment
Reasons
Adverse Event
FG00037 subjects
FG00138 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0055 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lack of Efficacy
FG0008 subjects
FG0019 subjects
FG0023 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0009 subjects
FG0017 subjects
FG0024 subjects
FG0036 subjects
FG004
Non-compliance with Study Drug
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Physician Decision
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0002 subjects
FG00112 subjects
FG0028 subjects
FG0034 subjects
FG004
Withdrawal by Subject
FG00021 subjects
FG00121 subjects
FG0028 subjects
FG0039 subjects
FG004
Participant did not want to take the three other treatments
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Migraines more frequent-GP advised to re-start Topiramate
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Travel and Coronavirus issues
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Open Label Extension
Type
Comment
Milestone Data
STARTED
FG0000 subjectsReported are only those participants who were enrolled in the OLE.
FG0010 subjectsReported are only those participants who were enrolled in the OLE.
FG0020 subjectsReported are only those participants who were enrolled in the OLE.
FG0030 subjectsReported are only those participants who were enrolled in the OLE.
FG0040 subjectsReported are only those participants who were enrolled in the OLE.
FG0050 subjectsReported are only those participants who were enrolled in the OLE.
FG0060 subjectsReported are only those participants who were enrolled in the OLE.
FG0070 subjectsReported are only those participants who were enrolled in the OLE.
FG008477 subjects
Treated at Least One Migraine Attack
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants who were treated with at least 1 dose of study drug, regardless of whether or not they undergo any study assessments.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind.
BG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
BG002
Control
Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to treat migraine attacks 1, 2 and 3.
Participants received one 50 mg Lasmiditan tablet and two 100 mg Lasmiditan matching placebo tablets to treat migraine attack 4.
BG003
100 mg Lasmiditan MEE
Participants received one 100 mg Lasmiditan tables with one 50 mg lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain the blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
BG004
200 mg Lasmiditan MEE
Participants received two 100 mg Lasmiditan tables with one 50 mg lasmiditan matching placebo tablet to maintain the blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
BG005
Control MEE
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000485
BG001486
BG002500
BG00355
BG00453
BG00554
BG0061633
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.90± 12.02
BG00141.70± 11.95
BG00240.60± 12.11
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000403
BG001418
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00044
BG00144
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00025
BG00128
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Austria
Title
Measurements
BG0005
BG0013
BG002
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 That Are Pain Free 2 Hours Postdose During the First Attack
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
All randomized participants who used at least 1 dose of study drug for an Intent-to-Treat (ITT) evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00025.8
OG00129.3
OG0028.4
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.83
2-Sided
95
2.56
5.73
Superiority
OG001
OG002
Regression, Logistic
<0.001
Primary
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
All randomized participants who experienced at least 2 successes or 2 failures during their first 2 or 3 ITT evaluable attacks. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Secondary
Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time.
All randomized participants who use at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks
Headache pain relief is defined as a reduction in pain severity from moderate to severe at baseline to mild or none at 2 hours postdose in at least 2 out of 3 attacks. To evaluate at least 2 out of 3 consistency endpoints, the results of ITT-evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT-evaluable attacks, only the first 3 with the same treatment will be considered.
All randomized participants who experienced a sufficient number of successes or failures, (2 successes or 2 failures ) during their first 2 or 3 ITT-evaluable attacks. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack
Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.
All randomized participants who received at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
24 Hours
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack
Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.
All randomized participants who received at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
48 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack. A triptan insufficient responder is defined as having one of the following: 1) Scoring ≤5 on 4 questions from the Migraine Treatment Optimization Questionnaire (mTOQ-6) that defines participants with poor or very poor response to their current regimen; 2) Indicated they obtained pain freedom at 2 hours in 0 out of 3, or 1 out of 3 attacks when treated with the most recent triptan, or 3) are not currently taking triptan and discontinued their most recent triptan due to lack of efficacy, tolerability issue, or contradictions to a past triptan.
All randomized participants who were triptan insufficient responders and used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Secondary
Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack
Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack. Disability was measured by determining the level of interference with normal activities with 4 response options including not at all; mild interference, marked interference; and need complete bed rest.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Secondary
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at the indicated assessment time. A subject is not counted as being pain-free at a specific time point if she or he used rescue or recurrence medication at or before the specific time point.
All randomized participants who were triptan insufficient responders and experienced a sufficient number of successes or failures, (2 successes or 2 failures ) during their first 2 or 3 ITT-evaluable attacks. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Secondary
Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack
MBS freedom is defined as the absence of the associated symptom of migraine (nausea, phonophobia, or photophobia) at the indicated assessment time that was identified at baseline as the most bothersome symptom.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack
Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
24 Hours
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack
Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack
Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in participants who were pain free at 2 hours.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
24 Hours
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack
Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
30 Minutes (Min) and 1 Hour (Hr) Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Secondary
Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that reflect the number of days reported as missed, or with reduced productivity at work or home and social events. Each question is answered as the number of days during the past 3 months of assessment, ranging from 0 to 90, with the total score being the summation of the 5 numeric responses. A higher value is indicative of more disability.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack
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. Reported are participants whose combined impression of change since taking the medicine was very much better and much better at 2 hours postdose.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack
The 24-hour Migraine Quality of Life Questionnaire (24-hr MQoLQ) has been specifically developed to measure the HRQoL of participants with migraine within a 24-hour period after having taken migraine medication A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, with lower scores indicating less impairment. The questionnaire will be administered 24 hours after dosing with study drug during each migraine. The analysis of variance (ANOVA) model was used with region and treatment adjusted for the overall treatment effect.
All randomized participants who used at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Mean
Standard Deviation
score on a scale
24 Hours Post First Dose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire
Treatment satisfaction was evaluated at the End of Study (EoS) visit by determining the participant's level of satisfaction (ranging from extremely dissatisfied to extremely satisfied); their willingness to take this treatment again (ranging from strongly disagree to strongly agree) and if they would they recommend this treatment to another participants (ranging from strongly disagree to strongly agree).
All randomized participants who use at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Control
Secondary
Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack
The EQ-5D-5L questionnaire is a participant-rated scale that assesses health status, it consists of 2 parts. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 possible levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems).The EQ-5D can be used to generate a health state index score, which is used to compute quality-adjusted life years for utilization in health economic analyses. The health state index score is 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) to 1 (perfect health), with higher scores indicating better health utility. ANCOVA was used to assess the effect of Lasmiditan over placebo or control. The model includes fixed categorical effect of treatment and geographic region and baseline as covariate.
All randomized participants who use at least 1 dose of study drug for an ITT evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Mean
Standard Deviation
score on a scale
Baseline, 24 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe to none at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
All randomized participants who experienced a sufficient number of successes or failures, (3 out of 4 attacks) during ITT evaluable attacks for any of the consistency analyses. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
All randomized participants who experienced a sufficient number of successes or failures, (3 successes or 2 failures ) during ITT-evaluable attacks for any of the consistency analyses. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
Secondary
Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack
Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.
All randomized participants who used at least 1 dose of study drug for an Intent-to-Treat (ITT) evaluable attack, defined as a treated attack of at least mild pain severity with any postdose pain severity assessments at or before 2 hours postdose. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
2 Hours Postdose
ID
Title
Description
OG000
100 mg Lasmiditan
Participants received one100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Time Frame
Up to 16 months
Description
All randomized participants who take at least 1 dose of study drug, regardless of whether or not they undergo any study assessments. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
100 Milligram (mg) Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
0
485
7
485
331
485
EG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
0
486
8
486
355
486
EG002
Main - Control
Control 1 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
0
500
7
500
184
500
EG003
100 mg Lasmiditan - MEE
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100-mg Lasmiditan matching placebo tablet to maintain blind.
0
55
1
55
31
55
EG004
200 mg Lasmiditan - MEE
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
0
53
0
53
40
53
EG005
MEE - Control
Control 1 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2 Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3, and one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
0
54
0
54
16
54
EG006
Open Label Extension
Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
1
477
19
477
326
477
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina unstable
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG0030 events0 affected55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected54 at risk
EG0061 events1 affected477 at risk
Palpitations
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Wolff-parkinson-white syndrome
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Cyst
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Abscess oral
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Otitis media
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Mucinous adenocarcinoma of appendix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Nasopharyngeal cancer stage iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected403 at risk
EG0010 events0 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Hemiplegic migraine
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Medication overuse headache
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ophthalmic migraine
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Serotonin syndrome
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Vestibular migraine
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected403 at risk
EG0010 events0 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected403 at risk
EG0010 events0 affected418 at risk
EG0021 events1 affected416 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected403 at risk
EG0011 events1 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected403 at risk
EG0010 events0 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Ovarian cyst torsion
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected403 at risk
EG0010 events0 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Appendicectomy
Surgical and medical procedures
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG0030 events0 affected55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected54 at risk
EG0061 events1 affected477 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG00019 events12 affected485 at risk
EG0019 events7 affected486 at risk
EG0023 events3 affected500 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected485 at risk
EG0012 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Acute vestibular syndrome
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0012 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Conductive deafness
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Deafness transitory
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected485 at risk
EG00110 events9 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG00068 events45 affected485 at risk
EG00179 events47 affected486 at risk
EG0027 events7 affected500 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0003 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Abnormal sensation in eye
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Cataract
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Diplopia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0014 events3 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Eye pain
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Eyelid skin dryness
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Metamorphopsia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Mydriasis
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Photophobia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected485 at risk
EG0015 events4 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Photopsia
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0003 events1 affected485 at risk
EG0016 events5 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Pupillary reflex impaired
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0005 events5 affected485 at risk
EG00112 events9 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Visual field defect
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Visual impairment
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG00111 events7 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0014 events3 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected485 at risk
EG0013 events3 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0016 events4 affected486 at risk
EG00214 events11 affected500 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0009 events7 affected485 at risk
EG0019 events6 affected486 at risk
EG0029 events8 affected500 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0009 events6 affected485 at risk
EG00115 events11 affected486 at risk
EG0023 events1 affected500 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected485 at risk
EG0013 events3 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0012 events1 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0023 events2 affected500 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0015 events2 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected485 at risk
EG0016 events6 affected486 at risk
EG0024 events2 affected500 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00069 events56 affected485 at risk
EG001105 events71 affected486 at risk
EG00234 events29 affected500 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected485 at risk
EG0013 events3 affected486 at risk
EG0023 events2 affected500 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0012 events2 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG00014 events13 affected485 at risk
EG00122 events18 affected486 at risk
EG00213 events11 affected500 at risk
EG003
Asthenia
General disorders
MedDRA 24.1
Systematic Assessment
EG00032 events23 affected485 at risk
EG00151 events31 affected486 at risk
EG0024 events3 affected500 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.1
Systematic Assessment
EG0004 events2 affected485 at risk
EG0017 events4 affected486 at risk
EG0023 events3 affected500 at risk
EG003
Chest pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Chills
General disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected485 at risk
EG0015 events5 affected486 at risk
EG0024 events3 affected500 at risk
EG003
Discomfort
General disorders
MedDRA 24.1
Systematic Assessment
EG0006 events5 affected485 at risk
EG00111 events7 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Fatigue
General disorders
MedDRA 24.1
Systematic Assessment
EG00080 events55 affected485 at risk
EG001104 events71 affected486 at risk
EG00221 events19 affected500 at risk
EG003
Feeling abnormal
General disorders
MedDRA 24.1
Systematic Assessment
EG0009 events9 affected485 at risk
EG00125 events19 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Feeling cold
General disorders
MedDRA 24.1
Systematic Assessment
EG00011 events6 affected485 at risk
EG0011 events1 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Feeling drunk
General disorders
MedDRA 24.1
Systematic Assessment
EG0006 events4 affected485 at risk
EG0012 events2 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Feeling hot
General disorders
MedDRA 24.1
Systematic Assessment
EG0004 events2 affected485 at risk
EG0018 events6 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Feeling of relaxation
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0012 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Gait disturbance
General disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected485 at risk
EG0014 events4 affected486 at risk
EG0020 events0 affected500 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hunger
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Illness
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0012 events2 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0012 events2 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Malaise
General disorders
MedDRA 24.1
Systematic Assessment
EG0009 events6 affected485 at risk
EG0019 events7 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0022 events1 affected500 at risk
EG003
Pain
General disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected485 at risk
EG0012 events2 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Peripheral swelling
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Pyrexia
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0013 events2 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Sensation of blood flow
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Sensation of foreign body
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Sense of oppression
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Swelling face
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Thirst
General disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0013 events3 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected403 at risk
EG0011 events1 affected418 at risk
EG0020 events0 affected416 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ear infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0015 events5 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Localised infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0008 events8 affected485 at risk
EG0018 events8 affected486 at risk
EG0029 events9 affected500 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0023 events3 affected500 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0003 events3 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Skin infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0007 events7 affected485 at risk
EG0012 events2 affected486 at risk
EG0024 events4 affected500 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Viral infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Blood folate decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood pressure decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood pressure increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Body temperature increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Heart rate decreased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Heart rate increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected485 at risk
EG0011 events1 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Heart rate irregular
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Muscle strength abnormal
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Pulse abnormal
Investigations
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Total bile acids increased
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0004 events4 affected485 at risk
EG0014 events3 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Food craving
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0012 events2 affected486 at risk
EG0023 events3 affected500 at risk
EG003
Axillary mass
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0013 events3 affected486 at risk
EG0023 events3 affected500 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00012 events8 affected485 at risk
EG00111 events8 affected486 at risk
EG0022 events2 affected500 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Muscle fatigue
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events4 affected485 at risk
EG0017 events7 affected486 at risk
EG0024 events4 affected500 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0005 events3 affected485 at risk
EG0019 events6 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG00036 events23 affected485 at risk
EG00145 events29 affected486 at risk
EG0023 events2 affected500 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0011 events1 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected485 at risk
EG0013 events3 affected486 at risk
EG0024 events4 affected500 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0014 events3 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0021 events1 affected500 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Lipoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected485 at risk
EG0010 events0 affected486 at risk
EG0020 events0 affected500 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FG008476 subjectsOne participant signed consent but decided against participating in the OLE period and was not dosed.
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008324 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008153 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
COVID-19
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00839 subjects
Participant refused to comply with face mask use
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Taking medication too restrictive for lifestyle
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00846 subjects
Participant didn't have disposition for OLE period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Non-compliance with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00824 subjects
Participant wanted to become pregnant
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00823 subjects
37.20
± 9.83
BG00437.20± 9.46
BG00538.60± 8.70
BG00641.30± 11.89
416
BG00343
BG00436
BG00540
BG0061356
Male
BG00082
BG00168
BG00284
BG00312
BG00417
BG00514
BG006277
47
BG0030
BG0040
BG0050
BG006135
Not Hispanic or Latino
BG000393
BG001390
BG002401
BG00319
BG00414
BG00515
BG0061232
Unknown or Not Reported
BG00048
BG00152
BG00252
BG00336
BG00439
BG00539
BG006266
27
BG0030
BG0040
BG0050
BG00680
Asian
BG00071
BG00172
BG00278
BG00353
BG00449
BG00551
BG006374
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
Black or African American
BG00012
BG0018
BG0027
BG0030
BG0040
BG0050
BG00627
White
BG000370
BG001368
BG002379
BG0032
BG0044
BG0053
BG0061126
More than one race
BG0000
BG0012
BG0021
BG0030
BG0040
BG0050
BG0063
Unknown or Not Reported
BG0007
BG0017
BG0028
BG0030
BG0040
BG0050
BG00622
3
BG0030
BG0040
BG0050
BG00611
Belgium
Title
Measurements
BG0009
BG00110
BG0029
BG0030
BG0040
BG0050
BG00628
China
Title
Measurements
BG00045
BG00144
BG00247
BG00350
BG00448
BG00547
BG006281
Czechia
Title
Measurements
BG00033
BG00132
BG00231
BG0030
BG0040
BG0050
BG00696
Denmark
Title
Measurements
BG0009
BG00110
BG00211
BG0030
BG0040
BG0050
BG00630
France
Title
Measurements
BG0007
BG0017
BG0028
BG0030
BG0040
BG0050
BG00622
Germany
Title
Measurements
BG00092
BG00189
BG00294
BG0030
BG0040
BG0050
BG006275
Hungary
Title
Measurements
BG0006
BG0016
BG0025
BG0030
BG0040
BG0050
BG00617
India
Title
Measurements
BG00012
BG00114
BG00213
BG0033
BG0041
BG0054
BG00647
Italy
Title
Measurements
BG0007
BG0017
BG0028
BG0030
BG0040
BG0050
BG00622
Mexico
Title
Measurements
BG00029
BG00132
BG00234
BG0030
BG0040
BG0050
BG00695
Netherlands
Title
Measurements
BG0003
BG0014
BG0023
BG0030
BG0040
BG0050
BG00610
Russia
Title
Measurements
BG00013
BG00112
BG00213
BG0032
BG0044
BG0053
BG00647
Spain
Title
Measurements
BG00018
BG00121
BG00222
BG0030
BG0040
BG0050
BG00661
Switzerland
Title
Measurements
BG0005
BG0017
BG0027
BG0030
BG0040
BG0050
BG00619
United Kingdom
Title
Measurements
BG000164
BG001162
BG002164
BG0030
BG0040
BG0050
BG006490
United States
Title
Measurements
BG00028
BG00126
BG00228
BG0030
BG0040
BG0050
BG00682
Odds Ratio (OR)
4.56
2-Sided
95
3.07
6.77
Superiority
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000340
OG001336
OG002373
Title
Denominators
Categories
Title
Measurements
OG00014.4
OG00124.4
OG0024.3
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
OG002
Regression, Logistic
<.001
Odds Ratio (OR)
3.77
2-Sided
95
2.10
6.76
Superiority
OG001
Regression, Logistic
<.001
Odds Ratio (OR)
7.24
2-Sided
95
4.13
12.67
Superiority
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00065.4
OG00165.2
OG00241.3
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.71
2-Sided
95
2.05
3.57
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.68
2-Sided
95
2.04
3.53
Superiority
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000332
OG001333
OG002320
Title
Denominators
Categories
Title
Measurements
OG00062.3
OG00166.7
OG00236.9
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
Regression, Logistic
<0.001
Odds Ratio (OR)
2.91
2-Sided
95
2.11
4.01
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.50
2-Sided
95
2.53
4.85
Superiority
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00013.6
OG00117.3
OG0024.3
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.52
2-Sided
95
2.05
6.02
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
4.67
2-Sided
95
2.77
7.88
Superiority
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG0009.3
OG00115.4
OG0024.3
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
OG002
Regression, Logistic
0.004
Odds Ratio (OR)
2.30
2-Sided
95
1.30
4.04
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
4.09
2-Sided
95
2.41
6.94
Superiority
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000183
OG001203
OG002193
Title
Denominators
Categories
Title
Measurements
OG00024.0
OG00125.6
OG0028.8
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.29
2-Sided
95
1.80
6.02
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.56
2-Sided
95
1.97
6.42
Superiority
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00018.6
OG00119.8
OG0029.5
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.22
2-Sided
95
1.48
3.33
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.46
2-Sided
95
1.65
3.67
Superiority
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG00017
OG00131
OG0027
Title
Denominators
Categories
Title
Measurements
OG00011.0
OG00120.1
OG0024.3
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
OG002
Regression, Logistic
0.031
Odds Ratio (OR)
2.73
2-Sided
95
1.10
6.78
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
5.64
2-Sided
95
2.40
13.25
Superiority
Units
Counts
Participants
OG000376
OG001395
OG002396
Title
Denominators
Categories
Title
Measurements
OG00040.4
OG00139.0
OG00228.0
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
1.74
2-Sided
95
1.29
2.35
Superiority
OG001
OG002
Regression, Logistic
0.001
Odds Ratio (OR)
1.63
2-Sided
95
1.21
2.20
Superiority
Units
Counts
Participants
OG000311
OG001307
OG002406
Title
Denominators
Categories
Title
Measurements
OG00019.6
OG00119.2
OG00229.3
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
0.46
2-Sided
95
0.33
0.65
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
0.43
2-Sided
95
0.30
0.60
Superiority
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00017.9
OG00121.0
OG0027.2
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.77
2-Sided
95
1.79
4.28
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.37
2-Sided
95
2.20
5.15
Superiority
Units
Counts
Participants
OG000108
OG001127
OG00237
Title
Denominators
Categories
Title
Measurements
OG00030.6
OG00122.0
OG00237.8
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Pain Freedom (30 Min)
Title
Measurements
OG0001.4
OG0011.6
OG0020.2
Pain Freedom (1Hr)
Title
Measurements
OG0006.0
OG00112.7
OG0022.0
Pain Relief (30 Min)
Title
Measurements
OG00018.6
OG00122.4
OG00214.0
Pain Relief (1 Hr)
Title
Measurements
OG00048.7
OG00147.2
OG00229.3
Freedom from MBS (30 Min)
Title
Measurements
OG00012.5
OG00114.4
OG00211.4
Freedom from MBS (1 Hr)
Title
Measurements
OG00023.7
OG00128.9
OG00222.0
No Disability Postdose During First Attack (30 Min)
Title
Measurements
OG0003.1
OG0012.3
OG0022.3
No Disability Postdose During First Attack (1 Hr)
Title
Measurements
OG0006.0
OG0019.9
OG0025.0
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
OG002
Pain Freedom 30 Min. Postdose
Regression, Logistic
0.086
Odds Ratio (OR)
6.40
2-Sided
95
0.77
53.37
Superiority
OG001
OG002
Pain Freedom 30 Min. Postdose
Regression, Logistic
0.065
Odds Ratio (OR)
7.24
2-Sided
95
0.89
59.08
Superiority
OG000
OG002
Pain Free 1 Hour Postdose
Regression, Logistic
0.004
Odds Ratio (OR)
3.08
2-Sided
95
1.42
6.68
Superiority
OG001
OG002
Pain Free 1 Hour Postdose
Regression, Logistic
<0.001
Odds Ratio (OR)
7.04
2-Sided
95
3.43
14.44
Superiority
OG000
OG002
Pain Relief 30 Min Postdose 100 mg
Regression, Logistic
0.065
Odds Ratio (OR)
1.41
2-Sided
95
0.98
2.03
Superiority
OG001
OG002
Pain Relief 30 Min. Postdose 200 mg
Regression, Logistic
0.001
Odds Ratio (OR)
1.77
2-Sided
95
1.25
2.52
Superiority
OG000
OG002
Pain Relief 1 Hour Postdose 100 mg
Regression, Logistic
<0.001
Odds Ratio (OR)
2.31
2-Sided
95
1.74
3.06
Superiority
OG001
OG002
Pain Relief 1 Hour Postdose 200 mg
Regression, Logistic
<0.001
Odds Ratio (OR)
2.18
2-Sided
95
1.64
2.88
Superiority
OG000
OG002
Freedom from MBS 30 Min 100 mg
Regression, Logistic
0.651
Odds Ratio (OR)
1.11
2-Sided
95
0.71
1.71
Superiority
OG001
OG002
Freedom from MBS 30 Min. 200 mg
Regression, Logistic
0.220
Odds Ratio (OR)
1.30
2-Sided
95
0.85
1.98
Superiority
OG000
OG002
Freedom from MBS 1 Hour 100 mg
Regression, Logistic
0.593
Odds Ratio (OR)
1.10
2-Sided
95
0.78
1.54
Superiority
OG001
OG002
Freedom from MBS 1 Hour 200 mg
Regression, Logistic
0.030
Odds Ratio (OR)
1.43
2-Sided
95
1.04
1.98
Superiority
OG002
Control
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000447
OG001437
OG002451
Title
Denominators
Categories
Title
Measurements
OG000-10.7± 24.36
OG001-12.0± 21.38
OG002-13.1± 21.40
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
OG002
ANCOVA
0.092
Superiority
OG001
OG002
ANCOVA
0.211
Superiority
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG00029.8
OG00130.0
OG00213.3
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
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
2.85
2-Sided
95
2.01
4.05
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.00
2-Sided
95
2.12
4.26
Superiority
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000289
OG001303
OG002293
Title
Denominators
Categories
Social Functioning
Title
Measurements
OG00012.4± 4.8
OG00112.1± 4.7
OG00211.7± 4.7
Migraine Symptoms
Title
Measurements
OG00012.4± 4.1
OG00112.5± 4.2
OG00211.4± 4.4
Feeling/Concern
Title
Measurements
OG00011.2± 4.3
OG00111.2± 4.5
OG00210.3± 4.2
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
OG002
Social Functioning
ANOVA
0.056
Superiority
OG001
OG002
Social Functioning
ANOVA
0.267
Superiority
OG000
OG002
Migraine Symptoms 100 mg
ANOVA
0.003
Superiority
OG001
OG002
Migraine Symptoms 200 mg
ANOVA
0.002
Superiority
OG000
OG002
Feeling/Concerns 100 mg
ANOVA
0.014
Superiority
OG001
OG002
Feelings/Concerns 200 mg
ANOVA
0.018
Superiority
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000452
OG001444
OG002460
Title
Denominators
Categories
Recommend Treatment - Agree/Strongly Agree
ParticipantsOG000451
ParticipantsOG001444
ParticipantsOG002460
Title
Measurements
OG00057.2
OG00158.1
OG00252.0
Willing to Take Treatment - Agree/Strongly Agree
ParticipantsOG000452
ParticipantsOG001444
ParticipantsOG002460
Title
Measurements
OG000
Extremely/Very Satisfied/Satisfied with Medication
ParticipantsOG000452
ParticipantsOG001444
ParticipantsOG002460
Title
Measurements
OG000
Prefer This Treatment
ParticipantsOG000141
ParticipantsOG001145
ParticipantsOG002134
Title
Measurements
OG000
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
OG002
Recommend Treatment - Agree Strongly Agree
Regression, Logistic
0.101
Odds Ratio (OR)
1.25
2-Sided
95
0.96
1.62
Superiority
OG001
OG002
Recommend Treatment Agree/Strongly Agree
Regression, Logistic
0.063
Odds Ratio (OR)
1.28
2-Sided
95
0.99
1.67
Superiority
OG000
OG002
Willing to Take This Treatment Again - Agree/Strongly Agree
Regression, Logistic
0.376
Odds Ratio (OR)
0.89
2-Sided
95
0.68
1.16
Superiority
OG001
OG002
Willing to Take This Treatment Again - Agree/Strongly Agree
Regression, Logistic
0.082
Odds Ratio (OR)
0.79
2-Sided
95
0.60
1.03
Superiority
OG000
OG002
Extremely/Very Satisfied
Regression, Logistic
0.096
Odds Ratio (OR)
1.25
2-Sided
95
0.96
1.62
Superiority
OG001
OG002
Extremely/Very Satisfied
Regression, Logistic
0.016
Odds Ratio (OR)
1.38
2-Sided
95
1.06
1.80
Superiority
OG000
OG002
Prefer This Treatment
Regression, Logistic
0.445
Odds Ratio (OR)
1.12
2-Sided
95
0.84
1.49
Superiority
OG001
OG002
Regression, Logistic
0.243
Odds Ratio (OR)
1.19
2-Sided
95
0.89
1.58
Superiority
OG001
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind.
OG002
Placebo
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000419
OG001434
OG002443
Title
Denominators
Categories
Title
Measurements
OG0000.2499± 0.25788
OG0010.2270± 0.29854
OG0020.2122± 0.25729
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
OG002
ANCOVA
0.142
Superiority
OG002
Control
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Units
Counts
Participants
OG000325
OG001306
OG002387
Title
Denominators
Categories
Title
Measurements
OG0007.4
OG00110.8
OG0022.6
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
OG002
Regression, Logistic
0.004
Odds Ratio (OR)
3.01
2-Sided
95
1.42
6.40
Superiority
OG001
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
4.58
2-Sided
95
2.22
9.47
Superiority
OG002
Control
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.