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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:15 PM
NCT ID: NCT02074358
Description: Study initiated February 2014 and completed April 2014
Frequency Threshold: 0
Time Frame: Day 1 to 30 days post last dose.
Study: NCT02074358
Study Brief: A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A: Apixaban + Placebo Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes. None None 0 15 1 15 View
Treatment B: Apixaban + Cofact (4-Factor PCC) Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes. None None 0 15 5 15 View
Treatment C: Apixaban + Beriplex P/N (4-Factor PCC) Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes. None None 0 15 2 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Traumatic Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 17.0 View