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 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
NCT ID:
NCT00664534
Description:
None
Frequency Threshold:
1
Time Frame:
None
Study:
NCT00664534
Study Brief:
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Premix Insulin Lispro | Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs | None | None | 7 | 169 | 52 | 169 | View |
| Glargine | Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs | None | None | 3 | 173 | 53 | 173 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.0 | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Castleman's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.0 | View |
| Amputation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 14.0 | View |
| Transurethral prostatectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.0 | View |
| Diabetic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 14.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 14.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 14.0 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 14.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | 14.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 14.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 14.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 14.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 14.0 | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Respiratory tract infection viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Viral pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.0 | View |