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 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT01142908
Description: Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Frequency Threshold: 5
Time Frame: Adverse events were collected through out the study from baseline thru completion.
Study: NCT01142908
Study Brief: Cardiovascular Intervention Improvement Telemedicine Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pharmacist CVD The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months. None None 126 215 0 215 View
Education Control The education control group - these participants will receive educational material about CVD reduction. None None 123 213 0 213 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Emergecy Room Visit NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Coronary Issues NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Orthopedic NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Study Safety Protocol NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Endocrine NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Optometry NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastro_Intestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic Reaction (non_med SE) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT General disorders None View
Medication Refill NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neurologic NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT General disorders None View
Psychological NON_SYSTEMATIC_ASSESSMENT General disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastro_Intestinal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Medication Refill NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Protocol Deviation NON_SYSTEMATIC_ASSESSMENT Investigations None View
Study Safety Protocol NON_SYSTEMATIC_ASSESSMENT Investigations None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Circulatory NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Endocrine NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurologic NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Orthopedic NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dermatologic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Protocol Deviation NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Coronary issues NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurologic NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medication Refill NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychological NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Endocrine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Non_Cardiac Pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatologic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Coronary issues NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gastro_Intestinal NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Orthopedic NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pulmonary NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Circulatory NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Coronary issues NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Emergency room visit NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neurologic NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Planned Surgery NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):