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: 2025-12-24 @ 3:42 PM
Ignite Modification Date: 2025-12-25 @ 1:51 PM
NCT ID: NCT00237692
Description: None
Frequency Threshold: 5
Time Frame: Overall length of study
Study: NCT00237692
Study Brief: Hypertension Intervention Nurse Telemedicine Study (HINTS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1- Control A group of hypertensive patients who receive usual care None None 43 147 0 147 View
Arm 2 - Nurse Behavioral Int Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention None None 71 148 0 148 View
Arm 3 - Nurse Med Managment Int Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support None None 68 149 0 149 View
Arm 4 - Combined Behavioral and Med Mgmt Int Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral \& medication management None None 60 147 0 147 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Circulatory SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
w/recurrent nosebleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cancer Tx SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Coronary SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dermatologic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastro-Intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General - ER visits SYSTEMATIC_ASSESSMENT General disorders None View
General - Med-Refill SYSTEMATIC_ASSESSMENT General disorders None View
General - Med Side Effect SYSTEMATIC_ASSESSMENT General disorders None View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neurologic SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Optometry SYSTEMATIC_ASSESSMENT Eye disorders None View
Orthopedic Issues SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary-Death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urology SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coronary - Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Safety Protocol SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):