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 @ 11:43 PM
Ignite Modification Date: 2025-12-25 @ 9:35 PM
NCT ID: NCT00950651
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00950651
Study Brief: A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tramadol HCl Contramid® Once A Day The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study. None None 3 215 159 215 View
Tramadol HCl Twice a Day (SR) The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study. None None 8 215 159 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Insufficiency NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Essential Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peritoneal Adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal Colic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tibia Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Angina Unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bladder Neoplasm NOS NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular Disorder NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Ischaemic Stroke NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sweating increased NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View