Adverse Events Module

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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 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT02647905
Description: None
Frequency Threshold: 0
Time Frame: 90 days post insertion or sensor removal and follow-up
Study: NCT02647905
Study Brief: Evaluation of the Accuracy of an Implanted Glucose Sensor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Accuracy Assessment, CGMS To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device 0 None 1 90 43 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgical procedure to remove sensor SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Food poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Syncope SYSTEMATIC_ASSESSMENT Vascular disorders None View
Carpal tunnel SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope-Vasovagal SYSTEMATIC_ASSESSMENT Vascular disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken toe SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rib injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sensor location site- Pain/discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ankle sprain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Candidiasis vaginal SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyslipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Common cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cracked tooth SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection-Tooth SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders None View
Infection-Upper Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blepharoplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Broken tooth SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
TMJ pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Device Fragement not recovered SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema, removal site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sensor location site- Pain/discomfort SYSTEMATIC_ASSESSMENT General disorders None View
IV site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dermatitis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
IV site Erythema SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erythema, Arm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View