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: 2025-12-26 @ 11:49 AM
Ignite Modification Date: 2025-12-26 @ 11:49 AM
NCT ID: NCT04146116
Description: Collected via survey
Frequency Threshold: 1
Time Frame: Within 24 hours of initial application
Study: NCT04146116
Study Brief: Nasal Decolonization for Orthopedic Trauma Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nasal Povidone-iodine Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic 0 None 0 51 6 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stinging in the Nose SYSTEMATIC_ASSESSMENT Product Issues None View
Burning sensation SYSTEMATIC_ASSESSMENT Product Issues None View
Sore Throat SYSTEMATIC_ASSESSMENT Product Issues None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View