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 patient may have experienced more than one AE.