Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:24 AM
Ignite Modification Date: 2025-12-26 @ 3:27 AM
NCT ID: NCT02439320
Description: All randomized participants who had received at least one dose of study drug.
Frequency Threshold: 0
Time Frame: up to 11 weeks
Study: NCT02439320
Study Brief: Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
100 mg Lasmiditan Any participant who received 100 milligrams (mg) lasmiditan administered PO. 0 None 0 630 258 630 View
200 mg Lasmiditan Any participant who received 200 milligrams (mg) lasmiditan administered PO. 0 None 2 609 280 609 View
Placebo Any participant who received placebo administered PO. 0 None 1 617 113 617 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Left ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Hyperacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.0 View
Conjunctival hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Mydriasis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Bowel movement irregularity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Hypoaesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Abasia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling drunk SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Feeling of relaxation SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.0 View
Breast cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Exposure to toxic agent SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Stress fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle atrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Systemic lupus erythematosus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Aura SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Autonomic nervous system imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Clumsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Coordination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Fine motor skill dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Intracranial pressure increased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Parosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sensory disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Sensory integrative dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Tunnel vision SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Affect lability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Apathy SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Blunted affect SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Depersonalisation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Dysphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Euphoric mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Hypnagogic hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Listless SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nervousness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Panic reaction SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Phonophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.0 View
Atrophic vulvovaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Skin sensitisation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.0 View