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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
NCT ID:
NCT05224258
Description:
Only Adverse Events during the study period were posted
Frequency Threshold:
0
Time Frame:
3-month Study Period
Study:
NCT05224258
Study Brief:
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Subjects 7-17 Years of Age Study Period | Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months. MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection) | 0 | None | 0 | 107 | 26 | 107 | View |
| Subjects 18-80 Years of Age Study Period | Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months. MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection) | 0 | None | 0 | 116 | 30 | 116 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Coeliac disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA26.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Infusion site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Infusion site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Medical device site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Medical device site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Medical device site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Medical device site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA26.0 | View |
| Allergy to vaccine | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Infusion site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Medical device site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Respiratory syncytial virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Rhinovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA26.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA26.0 | View |
| Acetonaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA26.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA26.0 | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA26.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA26.0 | View |
| Hand dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA26.0 | View |