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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:15 PM
NCT ID: NCT01929993
Description: Participants at risk: the ones originally included and who received one of the procedures, no matter who had been excluded from the primary outcome analysis.
Frequency Threshold: 0
Time Frame: Adverse events were observed during or through the first week after the procedures.
Study: NCT01929993
Study Brief: A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SWETZ Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode. SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix. None None 1 81 1 81 View
LLETZ Cone LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin. None None 1 78 1 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
vaginal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hysterectomy NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Needed general anesthesia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View