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: 2025-12-25 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:13 PM
NCT ID: NCT00960193
Description: 24 subjects were enrolled in this study. One subject was withdrawn from the study due to failure to arrive for the Day 15 Seville orange juice dose.
Frequency Threshold: 0
Time Frame: None
Study: NCT00960193
Study Brief: Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Seville Orange Juice Alone On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. None None 0 23 0 23 View
Colchicine With Seville Orange Juice On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18. None None 0 23 1 23 View
Colchicine Alone Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days. None None 0 24 5 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View