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 @ 5:45 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT05977868
Description: None
Frequency Threshold: 0
Time Frame: Until study completion, for a duration of up to three months after hospital discharge
Study: NCT05977868
Study Brief: Comparing Oral Versus Parenteral Antimicrobial Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Discharged with oral antibiotics 1 None 18 64 4 64 View
Control Discharged with IV antibiotics 0 None 7 30 8 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Readmission SYSTEMATIC_ASSESSMENT General disorders None View
Readmission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Readmission SYSTEMATIC_ASSESSMENT Infections and infestations None View
Readmission SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Readmission SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Readmission SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mortality SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Antibiotic Side Effect SYSTEMATIC_ASSESSMENT General disorders None View
Antibiotic Side Effect SYSTEMATIC_ASSESSMENT Infections and infestations None View
Antibiotic Side Effect SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Line Related Adverse Event SYSTEMATIC_ASSESSMENT Vascular disorders None View