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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT05284760
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 4
Time Frame: From screening up to 14 days after the last dose of soticlestat (Day 51)
Study: NCT05284760
Study Brief: A Study of Soticlestat Tablets in Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part A: Treatment B Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition. 0 None 0 72 5 72 View
Part A: Treatment C Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition. 0 None 0 72 0 72 View
Part B: Treatment D Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition. 0 None 0 24 0 24 View
Part B: Treatment E Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition. 0 None 0 24 2 24 View
Part A: Treatment A Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition. 0 None 0 72 4 72 View
Part B: Treatment F Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition. 0 None 0 24 1 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View