Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:18 PM
NCT ID: NCT00229658
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00229658
Study Brief: An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Type 1 Diabetes Insulin using patients with Type 1 diabetes None None 14 None 0 766 View
Type 2 Diabetes Insulin using patients with Type 2 diabetes None None 13 None 0 531 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrioventricular block complete NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Hernia obstructive NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Chronic lymphocytic leukaemia NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Ovarian granulosa-theca cell tumour NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.1 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Ureteric stenosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Ovarian cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Other Events(If Any):