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 @ 2:36 AM
Ignite Modification Date: 2025-12-26 @ 1:13 AM
NCT ID: NCT03224234
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT03224234
Study Brief: A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 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
Insulclock With Feedback (Group A) Participants will use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock with feedback: Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. 0 None 1 40 8 40 View
Insulclock Without Feedback (Group B) Participants will use the Insulclock, but will not receive feedback on insulin administration. At midpoint (week 12), patients will be converted to the alternate arm. Insulclock without feedback: Not feedback on insulin administration. 0 None 4 40 13 40 View
Pilot: Insulclock With Feedback (Group A) Participants use the Insulclock and receive daily information on their smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. 0 None 0 11 0 11 View
Pilot: Insulclock Without Feedback (Group B) Participants use the Insulclock, but will not receive feedback on insulin administration. During the study period, information is collected on problems with connectivity, malfunction or any problem with the Insulclock® device. 0 None 0 7 0 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stroke NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Surgical Procedures NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart Failure Readmission NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nausea and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Epigastric pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglicemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Toe injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain of muscular etiology NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Leg swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non serious work related muscular injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ear infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
CHF shortness of breath NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diabetic neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View