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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT02249832
Description: Safety population included all participants who enrolled in the study.
Frequency Threshold: 0
Time Frame: eighteen weeks for each subject (6 weeks of ankle training + 12 week FU period).
Study: NCT02249832
Study Brief: The General Use of Robots in Stroke Recovery: the Anklebot
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Seated Robotic Ankle Therapy All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training. 0 None 1 55 2 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
worsening baseline ankle pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
neuropathic pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View