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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT00983294
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00983294
Study Brief: Drug-Drug Interaction Study of Colchicine and Azithromycin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Colchicine Alone Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. None None 0 24 8 None View
Azithromycin Alone On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18. None None 0 22 5 None View
Colchicine With Steady-state Azithromycin On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast. None None 0 22 4 None View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cardiac flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View