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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT03467750
Description: Post-tonsillectomy bleeding requiring surgery is a known risk of tonsillectomy and is not considered to be a serious adverse event in this study.
Frequency Threshold: 0
Time Frame: Information on adverse events was collected among participants who completed the surgery, beginning at the time of consent and continued through the final assessment at complete recovery, up to 14 days after surgery.
Study: NCT03467750
Study Brief: Effect of Ketorolac on Post Adenotonsillectomy Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketorolac Participants randomized to the ketorolac group received 0.5mg/kg IV at the end of the adenotonsillectomy procedure, once hemostasis was achieved. 0 None 0 29 1 29 View
Standard of Care Participants randomized to this group received the pain management standard of care for the adenotonsillectomy procedure. 0 None 0 32 2 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-operative bleeding requiring surgery NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View