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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT02709005
Description: Solicited symptoms were counted as AEs if they developed or worsened after the baseline symptom toxicity. Laboratory abnormalities for protocol-specified labs were considered AEs if they worsened at Visit 2 from the baseline value and increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined laboratory parameters collected were white blood cells, hemoglobin, platelets, neutrophils, creatinine, AST, ALT, total bilirubin, and glucose (random).
Frequency Threshold: 5
Time Frame: Solicited urogenital AEs were collected following the first dose of the study product (Day 1) through Day 5. Laboratory AEs were collected at Visit 2 (Day 8-15). Serious adverse events and non-laboratory non-solicited AEs were collected following the first dose of the study product (Day 1) through Visit 3 (Day 22-31).
Study: NCT02709005
Study Brief: Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
5% Monolaurin Vaginal Gel Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration, and commonly referred to as glycerol monolaurate (GML). Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses. 0 None 0 72 59 72 View
Vehicle Placebo The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Participants were to receive intravaginal gel twice daily for three successive days for a total of 6 doses. 0 None 0 37 28 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vaginal Odour SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vulvovaginal Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vulvovaginal Pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vulvovaginal Dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vulvovaginal Inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V20.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V20.1 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V20.1 View
Vulvovaginal Mycotic Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V20.1 View
Vaginal Odour NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Vulvovaginal Burning Sensation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA V20.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA V20.1 View
Vulvovaginal Pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA V20.1 View