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 @ 7:33 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT03554603
Description: Bacteremia during the trial was considered a serious adverse event
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT03554603
Study Brief: Modified Reporting of Positive Urine Cultures Collected From Long Term Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Modified Reporting Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Modified Report: An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important. 2 None 0 51 34 51 View
Standard Reporting Microbiology laboratory will report identification and susceptibility results 0 None 1 49 27 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal Temperature NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Elevated White Blood Cell Count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Altered Mental Status NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachypnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View