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 @ 10:55 PM

Ignite Modification Date: 2025-12-25 @ 8:23 PM

NCT ID: NCT00930969

Description: None

Frequency Threshold: 3

Time Frame: Baseline through 2 years.

Study: NCT00930969

Study Brief: ST Segment Detection Study

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

ICD Indicated	Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.	None	None	86	175	20	175	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Angina pectoris	None	General disorders	None	View
Cardiac failure	None	General disorders	None	View
Cardiac failure acute	None	General disorders	None	View
Lead dislodgement	None	General disorders	None	View
NSTEMI	None	General disorders	None	View
Ventricular tachycardia	None	General disorders	None	View
Anaemia	None	General disorders	None	View
Chest pain	None	General disorders	None	View
Dyspnoea	None	General disorders	None	View
Chronic obstructive pulmonary disease	None	General disorders	None	View
Gastrointestinal haemorrhage	None	General disorders	None	View
Inappropriate device therapy	None	General disorders	None	View
Urinary tract infection	None	General disorders	None	View
Atrial fibrillation	None	General disorders	None	View
Atrial flutter	None	General disorders	None	View
Bleeding	None	General disorders	None	View
Cerebrovascular accident	None	General disorders	None	View
Cholecystitis acute	None	General disorders	None	View
Deep vein thrombosis	None	General disorders	None	View
Gastroenteritis	None	General disorders	None	View
Hypotension	None	General disorders	None	View
Implant site infection	None	General disorders	None	View
Intermittent claudication	None	General disorders	None	View
Ischaemic cardiomyopathy	None	General disorders	None	View
Non-cardiac chest pain	None	General disorders	None	View
Pulmonary embolus	None	General disorders	None	View
Seizure	None	General disorders	None	View
Syncope	None	General disorders	None	View
Acute renal insufficiency	None	General disorders	None	View
Atelectasis	None	General disorders	None	View
Abdominal hernia	None	General disorders	None	View
Abscess	None	General disorders	None	View
Acute coronary syndrome	None	General disorders	None	View
Adenocarcinoma	None	General disorders	None	View
Adverse drug reaction	None	General disorders	None	View
Ankle fracture	None	General disorders	None	View
Atrial tachycardia	None	General disorders	None	View
Bronchitis bacterial	None	General disorders	None	View
COPD Exacerbation	None	General disorders	None	View
Cardio-respiratory arrest	None	General disorders	None	View
Carotid artery stenosis	None	General disorders	None	View
Cellulitis	None	General disorders	None	View
Clostridium difficile sepsis	None	General disorders	None	View
Colitis ischaemic	None	General disorders	None	View
Colon cancer	None	General disorders	None	View
Dehydration	None	General disorders	None	View
Diverticular perforation	None	General disorders	None	View
Diverticulum	None	General disorders	None	View
Dressler's syndrome	None	General disorders	None	View
Endocarditis	None	General disorders	None	View
Faecaloma	None	General disorders	None	View
Fall	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Gastritis	None	General disorders	None	View
Gout	None	General disorders	None	View
Hypotension	None	General disorders	None	View
Haematuria	None	General disorders	None	View
Haemoptysis	None	General disorders	None	View
Hepatitis C	None	General disorders	None	View
Hypersensitivity	None	General disorders	None	View
Hypertension	None	General disorders	None	View
Implant site hematoma	None	General disorders	None	View
Incision site hematoma	None	General disorders	None	View
Incisional hernia	None	General disorders	None	View
Infected hydrocele	None	General disorders	None	View
Infected sebaceous cyst	None	General disorders	None	View
Lower extremity edema	None	General disorders	None	View
Lymph node abscess	None	General disorders	None	View
Mental status changes	None	General disorders	None	View
Musculoskeletal pain	None	General disorders	None	View
Nasal septum deviation	None	General disorders	None	View
Neuralgia	None	General disorders	None	View
Obesity	None	General disorders	None	View
Oedema	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Oesophageal carcinoma	None	General disorders	None	View
Orthostatic hypotension	None	General disorders	None	View
Pneumothorax	None	General disorders	None	View
Pain	None	General disorders	None	View
Pain in extremity	None	General disorders	None	View
Pancreatitis	None	General disorders	None	View
Phimosis	None	General disorders	None	View
Post-traumatic headache	None	General disorders	None	View
Presyncope	None	General disorders	None	View
Radiculopathy	None	General disorders	None	View
Rectal cancer	None	General disorders	None	View
Renal artery stenosis	None	General disorders	None	View
Renal failure acute	None	General disorders	None	View
Renal mass	None	General disorders	None	View
Respiratory failure	None	General disorders	None	View
Respiratory tract infection	None	General disorders	None	View
Sepsis	None	General disorders	None	View
Sepsis MRSA	None	General disorders	None	View
Septic shock	None	General disorders	None	View
Skin laceration	None	General disorders	None	View
Spinal osteoarthritis	None	General disorders	None	View
Staphylococcal bacteraemia	None	General disorders	None	View
Stomach mass	None	General disorders	None	View
Thyroglossal cyst	None	General disorders	None	View
Traumatic fracture	None	General disorders	None	View
Urosepsis	None	General disorders	None	View
Ventricular fibrillation	None	General disorders	None	View
Wound haemorrhage	None	General disorders	None	View
Angina Unstable	None	General disorders	None	View
Pneumonia	None	General disorders	None	View
Unstable angina	None	General disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Atrial fibrillation	None	General disorders	None	View
Angina pectoris	None	General disorders	None	View
Dyspnea	None	General disorders	None	View