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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT04047420
Description: COVID-19 pandemic related scheduling delays occurred for seven participants resulting in collection of pre-dose adverse events over a 9-10 month period prior to first dosing. Of the 23 participants enrolled, two of these seven participants did not return for first dosing, thus 21 participants received the one insert dose.
Frequency Threshold: 0
Time Frame: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.
Study: NCT04047420
Study Brief: Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Baseline (Pre-dosing) All participants who were enrolled in the study, prior to any inserts. 0 None 0 23 3 23 View
One Insert All participants who received a single TAF/EVG rectal insert 0 None 0 21 4 21 View
Two Inserts All participants who received two TAF/EVG rectal inserts 0 None 0 19 4 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reactogenicity event SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vulvovaginal discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View