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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT05507333
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the first administration of the Gedea Pessary until the end-of-investigation visit (e.g., 25 days)
Study: NCT05507333
Study Brief: Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gedea Pessary Gedea pessary administration Gedea pessary: Daily administration of the Gedea pessary for 6 consecutive days 0 None 0 26 16 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysmenorrhoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal burning sensation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal discomfort NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Vulvovaginal pruritus NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Anal pruritus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vulvovaginal pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View