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 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:16 AM
NCT ID: NCT00757627
Description: None
Frequency Threshold: 1
Time Frame: From baseline to end of week 4
Study: NCT00757627
Study Brief: Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Etoricoxib Etoricoxib 60 mg once a day (q.d.) None None 6 500 82 500 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peritoneal adhesion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung abscess, chest pain/tightness and tremor NON_SYSTEMATIC_ASSESSMENT General disorders None View
Traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urethritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema , face/eye /hand/leg NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal distension / flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain, upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypertension / elevated blood pressure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View