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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT01687218
Description: AEs are reported throughout follow-up. AEs are assigned to a regimen based on the reported or derived onset date being on or after the first visit of the regimen and before the start of the next regimen.
Frequency Threshold: 3
Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Study: NCT01687218
Study Brief: Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Product 1 Oral (Daily FTC/TDF) None None 1 192 85 192 View
Product 2 Rectal (Daily TFV RG 1% gel) None None 2 192 103 192 View
Product 3 Rectal (RAI-associated TFV RG 1% gel) None None 0 191 87 191 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal mucosa hyperaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal tenesmus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Proctitis gonococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Proctitis chlamydial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View