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 @ 2:53 PM
Ignite Modification Date: 2025-12-25 @ 1:19 PM
NCT ID: NCT00356759
Description: Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00356759
Study Brief: Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
12-weekly INR Patients had INR every 4 weeks but only every thisrd INR was true; the other two were sham INRs dampened to be within or close to therapeutic range. Thus, true dose assessment was in practice performed every 12 weeks 2 None 4 124 7 124 View
4-weekly INR Patients had INR every 4 weeks and all results were true. Thus, true dose assessments were performed every 4 weeks. 5 None 7 126 4 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal infarct SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Subconjunctival bleeding SYSTEMATIC_ASSESSMENT Eye disorders None View