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: 2025-12-25 @ 3:22 AM
Ignite Modification Date: 2025-12-26 @ 2:00 AM
NCT ID: NCT00393705
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00393705
Study Brief: Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Insulin Lispro LM + Insulin Lispro MM Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks. Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening. None None 3 139 26 139 View
Insulin Biphasic Aspart 30/70 or Insulin Lispro LM Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment). Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. None None 7 139 26 139 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Cervix carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Genital candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Carpal tunnel decompression SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Dental care SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Eye laser surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Influenza immunisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Aortic arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Venous insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Ear congestion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View