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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT03973320
Description: The primary outcome was "the incidences of (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death, and (iv) calculated perioperative intraoperative blood loss", and these events were recorded retrospectively. As a result, none of the three types of adverse events posed a risk to participants. This study collects past information and no new data was actively collected from individuals.
Frequency Threshold: 0
Time Frame: The time period to which adverse events (i.e. deaths) were collected was up to 30 days following a total hip arthroplasty surgery.
Study: NCT03973320
Study Brief: Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Primary Total Hip Arthroplasty This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients. 3 None 0 11292 18 11292 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View