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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT03286218
Description: All randomized participants who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: From Baseline to Study Completion (Up to 2 months)
Study: NCT03286218
Study Brief: A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Qualification Phase - Placebo Placebo was administered orally. 0 None 0 95 8 95 View
Treatment Phase - 200 mg Lasmiditan 200 mg of Lasmiditan was administered orally in one of five treatment periods. 0 None 0 55 42 55 View
Qualification Phase - Alprazolam 1 mg of alprazolam was administered orally. 0 None 0 94 74 94 View
Treatment Phase - Placebo Placebo was administered orally in one of five treatment periods. 0 None 0 55 12 55 View
Treatment Phase - 2 mg Alprazolam 2 mg alprazolam was administered orally in one of five treatment periods. 0 None 0 53 49 53 View
Treatment Phase - 100 mg Lasmiditan 100 mg of Lasmiditan was administered orally in one of five treatment periods. 0 None 0 55 33 55 View
Treatment Phase - 400 mg Lasmiditan 400 mg of Lasmiditan was administered orally in one of five treatment periods. 0 None 0 55 47 55 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling of relaxation SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Euphoric mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View