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: 2025-12-24 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT03715803
Description: None
Frequency Threshold: 0
Time Frame: All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
Study: NCT03715803
Study Brief: Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Calistar A Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses 0 None 0 91 30 91 View
Calistar S Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses 0 None 0 126 14 126 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reoperation for prolapse NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mesh erosion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View