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 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
NCT ID:
NCT04113694
Description:
None
Frequency Threshold:
0
Time Frame:
3 months
Study:
NCT04113694
Study Brief:
Evaluation of Extended Wear Infusion Set (EWIS) in Patients 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 |
|---|---|---|---|---|---|---|---|---|
| Humalog Subjects Extended Wear Infusion Set | Each Humalog subject was given 12 Extended Wear Infusion Sets to wear. Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours. | 0 | None | 2 | 132 | 59 | 132 | View |
| Novolog Subjects Extended Wear Infusion Set | Each Novolog subject was given 12 Extended Wear Infusion Sets to wear. Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours. | 0 | None | 1 | 127 | 60 | 127 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA23.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA23.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA23.0 | View |
| Complication of device removal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA23.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA23.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA23.0 | View |
| Diabetic ketosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA23.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Facial paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA23.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA23.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA23.0 | View |
| Incision site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA23.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Infusion site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Infusion site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site hypersensitivity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Infusion site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Infusion site vesicles | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA23.0 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA23.0 | View |
| Medical device site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Medical device site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Medical device site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Medical device site nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Medical device site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Medical device site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA23.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA23.0 | View |
| Onychomycosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA23.0 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA23.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA23.0 | View |
| Stress | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA23.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA23.0 | View |
| Suspected COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Tourette's disorder | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA23.0 | View |
| Vertigo positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA23.0 | View |
| Medical device site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA23.0 | View |