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 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
NCT ID:
NCT04588259
Description:
All presented AEs are TEAEs, defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of exposure to randomised treatment. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.
Frequency Threshold:
5
Time Frame:
Run-in period up to 8 weeks, randomised treatment period up to 16 weeks
Study:
NCT04588259
Study Brief:
Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With 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 |
|---|---|---|---|---|---|---|---|---|
| NovoRapid: Run-in period | Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 8 weeks. Insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. | 0 | None | 9 | 331 | 32 | 331 | View |
| Faster aspart | Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. | 0 | None | 10 | 150 | 55 | 150 | View |
| NovoRapid | Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. | 0 | None | 7 | 150 | 40 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25 | View |
| Arteriosclerosis coronary artery | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25 | View |
| Diabetic foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25 | View |
| Hepatitis B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25 | View |
| Hypoglycaemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25 | View |
| Neuritis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25 | View |
| Postmenopausal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25 | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25 | View |
| Gastric Polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25 | View |
| Large Intestine Polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25 | View |
| Diabetic nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25 | View |
| Small intestine adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | View |
| Patella Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25 | View |