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 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
NCT ID:
NCT05413369
Description:
Analysis was performed on the safety population.
Frequency Threshold:
5
Time Frame:
From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days). All-cause mortality was collected throughout the study, up to 67 weeks.
Study:
NCT05413369
Study Brief:
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| iGlarLixi | Participants self-administered iGlarLixi (100 U/mL insulin glargine + 100 or 50 mcg/mL lixisenatide respectively) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted. | 0 | None | 15 | 290 | 152 | 290 | View |
| IDegAsp | Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted. | 0 | None | 12 | 291 | 101 | 291 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchopulmonary Aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Gastrointestinal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Intraosseous Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | View |
| Cerebral Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Ischaemic Cerebral Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Vertebrobasilar Insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.0 | View |
| Sudden Hearing Loss | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 26.0 | View |
| Arteriosclerosis Coronary Artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.0 | View |
| Varicophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.0 | View |
| Lung Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | View |
| Gastric Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.0 | View |
| Rheumatoid Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.0 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 26.0 | View |
| Uterine Polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 26.0 | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.0 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |
| Femur Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.0 | View |
| Lipase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.0 | View |