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 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT03130257
Description: The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Frequency Threshold: 0
Time Frame: Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months.
Study: NCT03130257
Study Brief: Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clinic Blood Pressure Measurement Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period 0 None 5 172 38 172 View
Home Blood Pressure Measurement Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period 0 None 2 170 38 170 View
Kiosk Blood Pressure Measurement Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period 0 None 3 168 35 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization: Surgery for removal appendix, bowel resection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization: Knee replacement surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Severe allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hospitalization: Surgery to implant stents NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization: Surgery for enlarged prostate & bladder stones NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization: Back operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization: Bladder surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Discomfort, pain, irritation or bruisng from 24-hour monitor NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sleep disruption NON_SYSTEMATIC_ASSESSMENT General disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT General disorders None View
High cholesterol NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post-Traumatic Stress Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Shingles NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gluten intolerance NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Toothache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abnormal EKG NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Toe surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
MRSA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Low B12 and iron NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gall stones NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hernia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Loss in erection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Swelling of hands, lips NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Plantar fasciitus NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nerve pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg/hip injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Stomach flu/nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bacterial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Trigger finger NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Respiratory track infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain NOS NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acid reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Deteriorating vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Carpal tunnel NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thyroid nodules NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Stress NON_SYSTEMATIC_ASSESSMENT General disorders None View
Epigastric parasite infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nerve damage from frostbite NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Kidney stones NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View