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 @ 12:53 PM
Ignite Modification Date: 2025-12-25 @ 12:17 PM
NCT ID: NCT02365961
Description: Both treatment are standard of care.
Frequency Threshold: 0
Time Frame: Patients were assessed throughout their study participation, from surgery through the 3 month follow up.
Study: NCT02365961
Study Brief: Hip Scope Fascia-iliaca (FI) Block Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FI Block Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000) ropivicaine clonidine Epinephrine 0 None 0 41 1 41 View
Local Injection Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Noropin 0 None 0 43 1 43 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospital readmission SYSTEMATIC_ASSESSMENT General disorders None View