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: 2025-12-26 @ 5:18 PM
Ignite Modification Date: 2025-12-26 @ 5:18 PM
NCT ID: NCT03326206
Description: Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT03326206
Study Brief: Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
COPE participants Individuals with diabetes seen at a study site and enrolled in COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise. 8 None 2 173 54 173 View
Non-COPE participants Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics . 92 None 3 2885 493 2885 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Incident CVD SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inpatient hospitalization SYSTEMATIC_ASSESSMENT Endocrine disorders None View