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 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT00771758
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00771758
Study Brief: Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oxycodone IR 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg. None None 1 43 29 43 View
Placebo 1 capsule every 4 - 6 hr as needed for up to 10 days None None 0 21 6 21 View
Tapentadol IR 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg. None None 1 44 23 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View