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 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT03839394
Description: All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
Frequency Threshold: 0
Time Frame: Up to 72 weeks
Study: NCT03839394
Study Brief: Case Managers for CVD Risk Reduction in HIV Clinic
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Educational Pamphlets + Telephone Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module. Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. 0 None 3 25 9 25 View
Educational Pamphlets Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website. 0 None 3 24 3 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
incarcerated inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
deep venous thrombosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders SNOMED CT View
epididimytis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SNOMED CT View
stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View
auditory hallucinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders SNOMED CT View
rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SNOMED CT View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
esophageal mass NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
syncope NON_SYSTEMATIC_ASSESSMENT Cardiac disorders SNOMED CT View
colonic polyps NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cataract surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
assault NON_SYSTEMATIC_ASSESSMENT Social circumstances SNOMED CT View
anal condyloma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View
colonoscopy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
direct laryngoscopy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
upper endoscopy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
laryngeal mass NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SNOMED CT View
hip replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
gonorrhea NON_SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
scapular abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations SNOMED CT View
transurethral prostatectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures SNOMED CT View
inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SNOMED CT View