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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT01886794
Description: None
Frequency Threshold: 5
Time Frame: AE's were collected during the time the subjects were enrolled in the study, which was 4-6 weeks.
Study: NCT01886794
Study Brief: Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Postmenopausal, Topical Vaginal Cream Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse. 0 None 0 2 2 2 View
Pre-menopausal, no Topical Vaginal Cream Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. 0 None 0 3 0 3 View
Postmenopausal, Topical Placebo Cream Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vulvovaginal discomfort/itching SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View