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 @ 1:18 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT00420095
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00420095
Study Brief: A Study for Patients With Diabetes Mellitus (IOPA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Human Insulin Mix 30/70 Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks. None None 2 None 19 None View
Insulin Lispro Low Mix Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks. None None 1 None 23 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypoglycemic coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Localised infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Vertebrobasilar insufficiency NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Lacunar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Diabetic nephropathy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View