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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT02584660
Description: The safety population included all randomized participants who took at least 1 dose of study drug.
Frequency Threshold: 3
Time Frame: Approximately 2.5 years
Study: NCT02584660
Study Brief: A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
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 Participants received rivaroxaban 15 milligram (mg) twice daily up to Day 21 orally followed by rivaroxaban 20 mg once daily up to Days 90 orally. 0 None 5 49 15 49 View
Standard-of-care Participants received local Standard-of-care as per local protocol and is defined by the medical team caring for participants. 0 None 7 63 13 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 18.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.1 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.1 View
Systemic Inflammatory Response Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.1 View
Device Related Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.1 View
Embolic Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.1 View
Acute Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.1 View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.1 View
May-Thurner Syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 18.1 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.1 View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.1 View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18.1 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18.1 View
Head Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 18.1 View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 18.1 View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 18.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18.1 View