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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:52 AM
NCT ID: NCT04319718
Description: None
Frequency Threshold: 5
Time Frame: 1 month
Study: NCT04319718
Study Brief: Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Eudragit MK-2048 Vaginal Film Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®). MK-2048 High Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 68.1 mg of ammonio methacrylate copolymer type B (Eudragit®) 0 None 0 25 17 25 View
Low Eudragit MK-2048 Vaginal Film Single use of 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®). MK-2048 Low Eudragit Vaginal Film: 2" x 2" vaginal film containing 30 mg of MK-2048 and 41.5 mg of ammonio methacrylate copolymer type B (Eudragit®) 0 None 0 12 12 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vulvovaginal irritation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal odor NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Early menses NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal dryness NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Post-traumatic stress disorder, worsening NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abnormal vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vulvovaginal itching NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Unexpected vaginal bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Back pain, low NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View