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 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
NCT ID:
NCT04235504
Description:
None
Frequency Threshold:
0
Time Frame:
4 weeks of Run-in Phase, 6 months of Study Phase, 6 months of Continuation Phase
Study:
NCT04235504
Study Brief:
ADvanced Hybrid Closed Loop Study in Adult Population With Type 1 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 |
|---|---|---|---|---|---|---|---|---|
| Cohort A Run-in Phase | Subjects were using MDI with Flash Glucose Monitoring (FGM). | 0 | None | 1 | 105 | 21 | 105 | View |
| Cohort B Run-in Phase | Subjects were using MDI + Real-Time CGM. | 0 | None | 1 | 17 | 1 | 17 | View |
| Cohort A - Treatment Arm Study Phase | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase started using AHCL (stop MDI + FGM therapy at Visit 6A). | 0 | None | 1 | 41 | 19 | 41 | View |
| Cohort A - Control Arm Study Phase | In study phase, subjects on MDI with Flash Glucose Monitoring (FGM) in run-in phase continued using MDI + FGM. | 0 | None | 1 | 41 | 18 | 41 | View |
| Cohort B - Treatment Arm Study Phase | In study phase, subjects on MDI + Real-Time CGM in run-in phase started using AHCL (stop MDI + CGM therapy at Visit 6A). | 0 | None | 1 | 8 | 2 | 8 | View |
| Cohort B - Control Arm Study Phase | In study phase, subjects on MDI + Real-Time CGM in run-in phase continued using MDI + CGM. | 0 | None | 0 | 5 | 0 | 5 | View |
| All Patients Continuation Phase | All subjects were using AHCL in continuation phase. | 0 | None | 2 | 88 | 31 | 88 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fracture nonunion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Patella fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abnormal weight gain | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Adrenal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Catheter site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Choking sensation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | View |
| Deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA25.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA25.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA25.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Fibromyalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Genital abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA25.0 | View |
| Herpes ophthalmic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
| Immunisation reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA25.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Infusion site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Infusion site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Periarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Polycystic ovaries | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA25.0 | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA25.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA25.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Stress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA25.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA25.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA25.0 | View |
| Laboratory test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA25.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Lipohypertrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA25.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA25.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA25.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA25.0 | View |
| Blood sodium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA25.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Macular oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA25.0 | View |
| Open angle glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA25.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA25.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| VIth nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA25.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Viral rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Viral sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA25.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |
| Vitreous haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA25.0 | View |