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 @ 1:09 PM
Ignite Modification Date: 2025-12-25 @ 12:22 PM
NCT ID: NCT00984061
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00984061
Study Brief: Drug-Drug Interaction Study of Colchicine and Clarithromycin
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 With Clarithromycin On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin. None None 0 23 4 None View
Colchicine Alone On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg. None None 0 24 7 None View
Clarithromycin Alone On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals. None None 0 23 5 None View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA SOC View
skin laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA SOC View
pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
vision blurred NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders medDRA SOC View
epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
pallor NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA SOC View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
stomach discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View
vessel puncture site hematoma NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View