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 @ 5:53 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT02653768
Description: Adverse events were typically identified when participants told a study team member, during a routine contact (e.g., intervention contact, follow-up assessment contact) that a health event occurred.
Frequency Threshold: 0
Time Frame: 15 months for each participant
Study: NCT02653768
Study Brief: STepped Exercise Program for Knee OsteoArthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
STEP-KOA This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits. Stepped Exercise Program: STEP 1: Participants have access to an internet-based exercise program for knee OA. STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support. STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit 1 None 23 230 3 230 View
Arthritis Education (AE) The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to osteoarthritis and its management, based on established treatment guidelines. 0 None 7 115 0 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization due bypass of peripheral artery NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hospitalization for lymphatic leak following peripheral artery bypass NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospitzalization for cardiac stents NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fall leading to injury (not study related) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood clot in leg NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Heart block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hernia surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization following car accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Emergency Department Visit due to twisted ankle NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Emergncy room visit due to swollen legs and chest pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Persistent soreness following car accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalziation due to flu symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Emergency room visit due to a cold NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization due to infection after liver biopsy NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Prostate cancer diagnosis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Emergency department visit for knee pain after falling out of bed NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Torn ligament in knee NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mini-strokes NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emergency department visit for heat stroke NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization for cardiac catheterization and complidcations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospital visit due to high blood pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to aneurysm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization due to vertigo NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emergency department visit due to atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Knee replacement surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall with minor injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Increased hip pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View