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 @ 2:06 AM
Ignite Modification Date: 2025-12-26 @ 12:32 AM
NCT ID: NCT06046560
Description: Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later.
Study: NCT06046560
Study Brief: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Medication & Education-First Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. 1 None 2 69 36 69 View
Education-First Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy. 0 None 0 37 14 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genital Mycotic Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypovolemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Severe hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View