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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT03538756
Description: The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
Frequency Threshold: 5
Time Frame: Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
Study: NCT03538756
Study Brief: walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Baseline Cross-over Group A--Walkasins ON Then OFF Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits. 0 None 0 0 0 0 View
Baseline Cross-over Group B--Walkasins OFF Then ON Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits. 0 None 0 0 0 0 View
Single-Arm Long-Term Follow-up (Walkasins ON) During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, all the participants received Walkasins to wear over the next 52 weeks (single arm). They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning. 1 None 10 69 24 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalizations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalizations SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalizations SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospitalization SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Knee Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Falls with Minor Injuries SYSTEMATIC_ASSESSMENT General disorders None View
Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View