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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT03292432
Description: In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.
Frequency Threshold: 0
Time Frame: From study entry to study completion (approximately 48 weeks)
Study: NCT03292432
Study Brief: Triggered Escalating Real-time Adherence (TERA) Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care (SOC) Standard of care for adherence support at site 2 None 3 45 0 45 View
TERA Intervention (TERA) Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks 1 None 4 43 2 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Esophageal candidiasis and pelvic inflammatory disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gunshot wound to head SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Axillary abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumothorax acute recurrent with shortness of breath, hypoxia and hypokalemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HSV proctitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Facial cellulitis and MRSA positive wound of the tragus SYSTEMATIC_ASSESSMENT Infections and infestations None View
AIDS SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View