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: 2025-12-24 @ 9:12 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT03575104
Description: The number of subjects affected is the number of subjects with at least one event.
Frequency Threshold: 5
Time Frame: Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.
Study: NCT03575104
Study Brief: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Daridorexant 10 mg Daridorexant was administered as tablets, orally, once daily in the evening. 0 None 3 306 49 306 View
Daridorexant 25 mg Daridorexant was administered as tablets, orally, once daily in the evening. 0 None 3 308 28 308 View
Placebo Matching placebo was administered as tablets, orally, once daily in the evening. 0 None 4 306 30 306 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Microvascular coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22.1 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View