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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT01561703
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01561703
Study Brief: Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Patients will receive postoperative antibiotic after surgery. Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery . Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery None None 0 20 0 20 View
Control Patients will NOT receive postoperative antibiotic No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics None None 0 24 0 24 View
Serious Events(If Any):
Other Events(If Any):