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 @ 2:36 AM
Ignite Modification Date: 2025-12-26 @ 1:13 AM
NCT ID: NCT03012334
Description: All randomized participants who received study drug.
Frequency Threshold: 5
Time Frame: Up To 35 days
Study: NCT03012334
Study Brief: The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. 0 None 1 85 8 85 View
Lasmiditan 50mg Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. 0 None 0 87 34 87 View
Lasmiditan 100mg Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. 0 None 0 86 47 86 View
Lasmiditan 200mg Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. 0 None 0 89 62 89 View
Alprazolam 1mg Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning. 0 None 0 85 71 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebellar haematoma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View