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 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:49 AM
NCT ID: NCT03643705
Description: Participants were assessed for adverse events systematically by the study nurse at each 4-month study visit. This included any self-reported events as well as a review of the electronic health record.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03643705
Study Brief: A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nurse Intervention This multi-component intervention will consist of four evidence-based components delivered at 4 in-person visits (0, 4, 8, and 12 months) and by telephone contact: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home blood pressure monitoring, and (4) electronic medical records support tools. Multi-component intervention: 4 components as described 2 None 30 149 44 149 View
Education Control Participants in the education control arm will receive general prevention education delivered at 4 in-person visits (0, 4, 8, and 12 months), which will consist of evidence-based material on diet, exercise, smoking, sexually transmitted infections, and cancer prevention. General prevention education: General education as described 2 None 22 148 45 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-study related events SYSTEMATIC_ASSESSMENT General disorders None View
Emergency room visit for chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emergency room visit or hospitalization for high home blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Acute kidney injury due to antihypertensive medication SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
myalgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
possible angioedema SYSTEMATIC_ASSESSMENT Immune system disorders None View
non study related events SYSTEMATIC_ASSESSMENT General disorders None View