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 @ 7:00 PM
Ignite Modification Date: 2025-12-25 @ 4:33 PM
NCT ID: NCT02829957
Description: None
Frequency Threshold: 5
Time Frame: Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.
Study: NCT02829957
Study Brief: RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rivaroxaban Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months 0 None 0 8 4 8 View
Apixaban Apixaban: 10mg BID for 7 days, then 5mg BID for three months 0 None 0 11 5 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Crossover to another anticoagulant NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
PBAC > 100 NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View
Anticoagulant discontinued for more than 48 hours NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View
Worsening DVT NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View
Bleeding that causes unplanned visit to a healthcare provider NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (10.0) View