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: 2025-12-25 @ 4:48 AM
Ignite Modification Date: 2025-12-26 @ 3:49 AM
NCT ID: NCT01929018
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT01929018
Study Brief: Collaborative-care Rehabilitation After Dysvascular Amputation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exercise, Activity, and Self-management Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions. Exercise: Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period. Walking Program: A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks. Health Self-Management Support: Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period. 0 None 4 19 14 19 View
Home and Phone Visit No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status. 0 None 9 19 11 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Foot Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View