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 @ 6:39 PM
Ignite Modification Date: 2025-12-25 @ 4:09 PM
NCT ID: NCT04964557
Description: The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
Frequency Threshold: 5
Time Frame: On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
Study: NCT04964557
Study Brief: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD8233 AZD8233 for subcutaneous use. 3 None 18 207 69 207 View
Placebo Matching placebo solution for subcutaneous injection. 0 None 12 203 62 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Amaurosis fugax SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Coagulation time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Metastatic malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Squamous cell carcinoma of lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Transitional cell carcinoma urethra SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25.0 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Bipolar i disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25.0 View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25.0 View