An Open-label, Long-term, Safety Study of Lasmiditan for... | NCT02565186

ID	Type	Description
H8H-CD-LAHL	Other Identifier	Eli Lilly and Company
2015-005674-37	EudraCT Number
COL MIG-305	Other Identifier	Colucid

Status Module

Name	Class
CoLucid Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Lasmiditan 100mg	Experimental	Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Drug: Lasmiditan
Lasmiditan 200mg	Experimental	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	Drug: Lasmiditan

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan	Drug	oral tablet	Lasmiditan 100mg Lasmiditan 200mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least 1 Treatment Emergent Adverse Event	An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.	Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose	Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).	Up to 12 months
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With Medical Resource Utilization	Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.	Up to 12 months

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Southview Medical Group		Birmingham	Alabama	35205	United States
Simon Williamson Clinic

PubMed Identifier	Type	Citation	Retractions
37965170	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.
34366152	Derived	Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R. Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies. Clin Ther. 2021 Jun;43(6):1066-1078. doi: 10.1016/j.clinthera.2021.04.004. Epub 2021 Aug 6.

ID	Title	Description
FG000	Lasmiditan 100mg	Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 9, 2018	Jul 10, 2020

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

Number of Participants With at Least 1 Treatment Emergent Adverse Event

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

All randomized participants who received at least one dose of study drug.

Posted

Number

Participants

Up to 12 months

ID	Title	Description
OG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
OG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Units	Counts
Participants	OG000991 OG0011039

Title

Denominators

Categories

Title	Measurements
	OG000447 OG001545

Secondary

Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose

Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).

All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.

Posted

Number

Percentage of PF Migraine Attacks

Up to 12 months

Migraine Attacks

ID	Title	Description
OG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
OG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Units	Counts
Participants

Secondary

Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose

MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.

All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.

Posted

Number

Percentage of MBS-Free Migraine Attacks

Up to 12 months

Migraine Attacks

ID	Title	Description
OG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
OG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Units	Counts
Participants

Other Pre-specified

Percentage of Participants With Medical Resource Utilization

Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.

All randomized participants who received at least one dose of study drug.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
OG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Bradycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events2 affected1,039 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Abscess limb	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Appendicitis perforated	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Carbuncle	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Coccidioidomycosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Diverticulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0012 events2 affected1,039 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Suture rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Thyroid cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Relapsing-remitting multiple sclerosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected845 at risk EG0011 events1 affected887 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Anxiety	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Drug abuse	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Mental status changes	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Suicide attempt	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Pharyngeal swelling	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0010 events0 affected1,039 at risk
Hypertensive urgency	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Bundle branch block left	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Palpitations	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0006 events3 affected991 at risk EG0015 events5 affected1,039 at risk
Tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events2 affected1,039 at risk
Diplacusis	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0015 events1 affected1,039 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0015 events4 affected1,039 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG00015 events10 affected991 at risk EG00153 events24 affected1,039 at risk
Altered visual depth perception	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Blindness transient	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Cataract	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Dyschromatopsia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Eye disorder	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events1 affected1,039 at risk
Iritis	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Metamorphopsia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events3 affected1,039 at risk
Miosis	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Papilloedema	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Photophobia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Photopsia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0016 events5 affected1,039 at risk
Strabismus	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Vision blurred	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0018 events6 affected1,039 at risk
Visual impairment	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0007 events3 affected991 at risk EG00123 events8 affected1,039 at risk
Vitreous floaters	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0015 events5 affected1,039 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events1 affected1,039 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events3 affected1,039 at risk
Dental caries	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected991 at risk EG00112 events6 affected1,039 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0012 events2 affected1,039 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events2 affected1,039 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00047 events39 affected991 at risk EG00181 events55 affected1,039 at risk
Oral pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0011 events1 affected1,039 at risk
Retching	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Toothache	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG00018 events17 affected991 at risk EG00112 events11 affected1,039 at risk
Asthenia	General disorders	MedDRA 22.1	Systematic Assessment	EG00038 events15 affected991 at risk EG00148 events24 affected1,039 at risk
Chest discomfort	General disorders	MedDRA 22.1	Systematic Assessment	EG00064 events3 affected991 at risk EG0018 events4 affected1,039 at risk
Chills	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events3 affected1,039 at risk
Discomfort	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events3 affected1,039 at risk
Facial pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events1 affected1,039 at risk
Fatigue	General disorders	MedDRA 22.1	Systematic Assessment	EG00090 events47 affected991 at risk EG001159 events64 affected1,039 at risk
Feeling abnormal	General disorders	MedDRA 22.1	Systematic Assessment	EG00011 events7 affected991 at risk EG0019 events8 affected1,039 at risk
Feeling cold	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events1 affected1,039 at risk
Feeling drunk	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected991 at risk EG0014 events2 affected1,039 at risk
Feeling hot	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events3 affected1,039 at risk
Feeling jittery	General disorders	MedDRA 22.1	Systematic Assessment	EG0009 events7 affected991 at risk EG00111 events5 affected1,039 at risk
Feeling of relaxation	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0019 events1 affected1,039 at risk
Gait disturbance	General disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected991 at risk EG0016 events4 affected1,039 at risk
Hunger	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Influenza like illness	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Injection site erythema	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Injection site swelling	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Malaise	General disorders	MedDRA 22.1	Systematic Assessment	EG0005 events3 affected991 at risk EG0013 events2 affected1,039 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0014 events4 affected1,039 at risk
Oedema	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Oedema peripheral	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Swelling face	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events2 affected1,039 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Sphincter of oddi dysfunction	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Seasonal allergy	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Acute sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Atypical pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Body tinea	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0013 events3 affected1,039 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Conjunctivitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Fungal skin infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Furuncle	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Gingivitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0013 events3 affected1,039 at risk
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0014 events4 affected1,039 at risk
Labyrinthitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Lyme disease	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0019 events9 affected1,039 at risk
Otitis externa	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Otitis media acute	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Pharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0012 events2 affected1,039 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Rhinitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Sinusitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0018 events8 affected1,039 at risk
Tooth abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG00010 events10 affected991 at risk EG0016 events6 affected1,039 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected991 at risk EG0015 events5 affected1,039 at risk
Viral infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events2 affected991 at risk EG0012 events2 affected1,039 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0010 events0 affected1,039 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Maternal exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected845 at risk EG0010 events0 affected887 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Blood creatinine increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Blood glucose increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Blood phosphorus decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Blood pressure decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events2 affected1,039 at risk
Blood pressure diastolic increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Blood pressure increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0012 events2 affected1,039 at risk
Blood triglycerides increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Electrocardiogram t wave biphasic	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Haematocrit decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Heart rate decreased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Heart rate increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Heart rate irregular	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hepatic enzyme increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Norovirus test positive	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Urine analysis abnormal	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Weight increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
White blood cells urine positive	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0012 events2 affected1,039 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events3 affected1,039 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0013 events3 affected1,039 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected991 at risk EG0016 events6 affected1,039 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Ligament laxity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00012 events1 affected991 at risk EG00117 events9 affected1,039 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected991 at risk EG0018 events6 affected1,039 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0006 events5 affected991 at risk EG00112 events7 affected1,039 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG00023 events9 affected991 at risk EG00149 events16 affected1,039 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0012 events2 affected1,039 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events2 affected1,039 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected845 at risk EG0010 events0 affected887 at risk
Akathisia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected991 at risk EG00124 events2 affected1,039 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Aphasia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Ataxia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00011 events3 affected991 at risk EG00131 events7 affected1,039 at risk
Aura	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Balance disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00021 events7 affected991 at risk EG00131 events19 affected1,039 at risk
Cognitive disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0005 events4 affected991 at risk EG0014 events3 affected1,039 at risk
Coordination abnormal	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0014 events3 affected1,039 at risk
Disturbance in attention	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0019 events6 affected1,039 at risk
Dizziness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG000336 events156 affected991 at risk EG001647 events220 affected1,039 at risk
Dysarthria	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Dysgeusia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Dyskinesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Fine motor skill dysfunction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0015 events3 affected1,039 at risk
Head discomfort	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0017 events5 affected1,039 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0015 events5 affected1,039 at risk
Hypersomnia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0012 events1 affected1,039 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00016 events13 affected991 at risk EG00131 events21 affected1,039 at risk
Lethargy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00036 events20 affected991 at risk EG00134 events14 affected1,039 at risk
Medication overuse headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Memory impairment	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0013 events2 affected1,039 at risk
Mental impairment	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Migraine	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00010 events9 affected991 at risk EG0019 events9 affected1,039 at risk
Mononeuropathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Neuralgia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG00084 events53 affected991 at risk EG001293 events86 affected1,039 at risk
Parosmia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0008 events5 affected991 at risk EG0015 events4 affected1,039 at risk
Sciatica	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Sedation	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0009 events3 affected991 at risk EG0017 events5 affected1,039 at risk
Sensory disturbance	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events1 affected1,039 at risk
Sinus headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Sleep paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Somnolence	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG000153 events77 affected991 at risk EG001290 events95 affected1,039 at risk
Speech disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Stupor	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Tarsal tunnel syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Tension headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0012 events2 affected1,039 at risk
Tremor	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0008 events8 affected991 at risk EG00119 events14 affected1,039 at risk
Visual field defect	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0012 events2 affected1,039 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0008 events4 affected991 at risk EG00123 events6 affected1,039 at risk
Affect lability	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Agitation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0003 events2 affected991 at risk EG0012 events1 affected1,039 at risk
Anxiety	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG00012 events8 affected991 at risk EG0019 events9 affected1,039 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Confusional state	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events3 affected1,039 at risk
Depersonalisation/derealisation disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Depressed mood	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0004 events4 affected991 at risk EG0013 events3 affected1,039 at risk
Disorientation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG00111 events8 affected1,039 at risk
Dysphoria	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0013 events3 affected1,039 at risk
Emotional distress	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Enuresis	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Euphoric mood	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0007 events5 affected991 at risk EG00122 events11 affected1,039 at risk
Fear	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hallucination	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected991 at risk EG0013 events3 affected1,039 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hypnagogic hallucination	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Insomnia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0005 events5 affected991 at risk EG00110 events7 affected1,039 at risk
Irritability	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Listless	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Major depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Mental fatigue	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Mood swings	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Nervousness	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Nightmare	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0017 events3 affected1,039 at risk
Panic attack	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0013 events3 affected1,039 at risk
Phonophobia	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Restlessness	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0007 events6 affected991 at risk EG0016 events5 affected1,039 at risk
Sleep disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Proteinuria	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Renal pain	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected845 at risk EG0011 events1 affected887 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected845 at risk EG0010 events0 affected887 at risk
Aphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG00121 events3 affected1,039 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0013 events3 affected1,039 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0011 events1 affected1,039 at risk
Nasal odour	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0010 events0 affected1,039 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected991 at risk EG0015 events4 affected1,039 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0005 events2 affected991 at risk EG0011 events1 affected1,039 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0011 events1 affected1,039 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Flushing	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0014 events3 affected1,039 at risk
Hot flush	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected991 at risk EG0015 events4 affected1,039 at risk
Hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0012 events2 affected1,039 at risk
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk
Pallor	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected991 at risk EG0011 events1 affected1,039 at risk
Peripheral coldness	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected991 at risk EG0010 events0 affected1,039 at risk

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

ID	Title	Description
BG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
BG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lasmiditan 100mg	Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	0	991	29	991	446	991
EG001	Lasmiditan 200mg	Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.	0	1,039	36	1,039	543	1,039