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 @ 4:31 AM
Ignite Modification Date: 2025-12-26 @ 3:33 AM
NCT ID: NCT02410018
Description: None
Frequency Threshold: 5
Time Frame: Day 0 through 28 days.
Study: NCT02410018
Study Brief: Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 - Uterine Artery Embolization Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. 0 None 0 2 2 2 View
Cohort 2 - Uterine Artery Embolization Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent. 0 None 0 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fibroid expulsion NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-embolization Syndrome NON_SYSTEMATIC_ASSESSMENT Investigations None View