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 @ 9:31 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT02703532
Description: None
Frequency Threshold: 0
Time Frame: Adverse events related to the intervention were collected from the time of providing consent to participate in the study through the one month post-treatment study follow-up visit (approximately 7 weeks after the baseline assessment).
Study: NCT02703532
Study Brief: Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CARE-CITE Education Program Carepartners Carepartners (those assisting in the care of a stroke survivor) participated in online CARE-CITE education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT). 0 None 0 21 0 21 View
Traditional Education Carepartners Carepartners (those assisting in the care of a stroke survivor) participated in traditional education while their partner (the stroke survivor) received constraint-induced movement therapy (CIMT). 0 None 0 11 0 11 View
Stroke Survivors With CARE-CITE Carepartners Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in online CARE-CITE education. 0 None 0 21 9 21 View
Stroke Survivors With Traditional Education Carepartners Participants who have survived a stroke received constraint-induced movement therapy (CIMT) while their carepartner participated in traditional education. 0 None 1 11 3 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower extremity cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart rate increase NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle soreness or pain that limits participation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View