Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:09 AM
Ignite Modification Date: 2025-12-26 @ 4:13 AM
NCT ID: NCT03977727
Description: Adverse event information was collected at all phone or office visits during the trial.
Frequency Threshold: 0
Time Frame: Approximately 20 weeks. The entire duration of the subjects study period.
Study: NCT03977727
Study Brief: FIasp® vs. Novolog® in Type 1 Diabetics Using 670G Medtronic Pump
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fiasp/Novolog 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII 0 None 1 19 11 19 View
Novolog/Fiasp 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII 0 None 0 18 7 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Herniated Disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non Proliferative Diabetic Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders None View
Worsening of Seasonal Allergic Rhinitis SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Redness at infusion site (right abdomen) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Trivial tricuspid regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Trivial mitral regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
First Degree AV Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittent Heart Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittent bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening of Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conjuntivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gasteroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Herniated Disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Cramps SYSTEMATIC_ASSESSMENT General disorders None View
Emesis SYSTEMATIC_ASSESSMENT General disorders None View
Traveler's Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatial Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritation at Infusion site (abdoment) SYSTEMATIC_ASSESSMENT Product Issues None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right Thumb laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Common Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening of hypocalcemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
erythema at infusion site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right index finger dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Triangular fibrocartilage band tear (left wrist) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening of hypothyroidsm SYSTEMATIC_ASSESSMENT Endocrine disorders None View
myalgia (bilateral shoulders0 SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ecchymosis (bilateral hands) SYSTEMATIC_ASSESSMENT General disorders None View
acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Center involved diabetic macular edema (right eye) SYSTEMATIC_ASSESSMENT Eye disorders None View
Vasovagal Syncope SYSTEMATIC_ASSESSMENT General disorders None View