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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT00922766
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00922766
Study Brief: Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dalteparin Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks. None None 4 617 23 617 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardio-respiratory Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Left Ventricular Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Pneumonia Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal Pain Lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gingival Bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Lower Respiratory Tract Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory Rate NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hemiplegia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pruritus Generalised NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Venous Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View