Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-24 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT05366751
Description: The Safety Set: all participants who were administered at least one dose of SAGE-324. All participants received SAGE-324 according to a predefined up-titration scheme as follows: 15 mg from Day 1 to Day 14, followed by up-titration to 30 mg from Day 15 to Day 28, then to 45 mg from Day 29 to Day 42, and then 60 mg starting on Day 43. Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.
Frequency Threshold: 5
Time Frame: Up to 814 days
Study: NCT05366751
Study Brief: A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SAGE-324 Participants received SAGE-324 15 mg from Day 1 to Day 14, followed by up-titration to 30 mg from Day 15 to Day 28, then to 45 mg from Day 29 to Day 42, and then 60 mg starting on Day 43, orally, once daily. 0 None 6 97 86 97 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Feeling abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View