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. 2012 Jan;3(1):27–42. doi: 10.1177/1947603511417616

Table 5.

Adverse Events (AEs) Reported during the 12-Month Time Course of the Investigator-Initiated Trial with the Spheroids in co.don chondrosphere

AE (reported term) MedDRA preferred term (PT) version 13.1 MedDRA system organ class (SOC) version 13.1 No. of patients with an AEa Intensity of the AE Seriousness of the AE Relation to transplantation surgery Causally related to co.don chondrosphere
Swelling Swelling General disorders and administration site conditions 1 Mild Nonserious Yes No
Knee joint effusion Joint effusion Musculoskeletal and connective tissue disorders 1 Mild Nonserious Yes Probable
Blocking Joint lock Musculoskeletal and connective tissue disorders 2 Moderate Nonserious Yes Possible
Thrombosis (superficial) Thrombophlebitis (superficial) Vascular disorders 1 Moderate Nonserious Yes No
Infection Infection Infections and infestations 1 Severe Nonserious Yes No
Deep vein thrombosis Deep vein thrombosis Vascular disorders 1 Severe Serious Yes No
Pulmonary embolism Pulmonary embolism Respiratory, thoracic, and mediastinal disorders 1 Severe Serious Yes No
a

A patient may have experienced more than one AE.