Table 3.

The ESCEO recommendations regarding the main (essential) organ systems to be considered for adverse event reporting within the results sections of manuscripts on clinical trials on anti-osteoarthritis medications

Treatment or treatment category	MedDRA SOCs [88]
Topical treatments (NSAID or other)	Skin and subcutaneous tissue disorders General disorders and administration site conditions Infections and infestations Pregnancy, puerperium and perinatal conditions Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Oral NSAIDs (including COX-2 inhibitors)	Cardiac disorders Gastrointestinal disorders Vascular disorders Renal and urinary disorders Blood and lymphatic system disorders Hepatobiliary disorders Respiratory, thoracic and mediastinal disorders Pregnancy, puerperium and perinatal conditions Surgical and medical procedures Product issues Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Immune system disorders Skin and subcutaneous tissue disorders
SYSADOAs (including glucosamine, chondroitin, diacerein, ASU, oral HA, etc.)	Gastrointestinal disorders Skin and subcutaneous tissue disorders Pregnancy, puerperium and perinatal conditions Blood and lymphatic system disorders Endocrine disorders Hepatobiliary disorders Renal and urinary disorders Product issues Eye disorders
Intra-articular treatments (HA, corticosteroids, PRP, etc.)	Infections and infestations General disorders and administration site conditions Surgical and medical procedures Skin and subcutaneous tissue disorders Endocrine disorders Pregnancy, puerperium and perinatal conditions Injury, poisoning and procedural complications Musculoskeletal and connective tissue disorders Product issues Vascular disorders Gastrointestinal disorders
Opioids	Psychiatric disorders Nervous system disorders Gastrointestinal disorders Hepatobiliary disorders Pregnancy, puerperium and perinatal conditions Cardiac disorders Respiratory, thoracic and mediastinal disorders Injury, poisoning and procedural complications Renal and urinary disorders Product issues
Other new anti-OA medication	The ESCEO safety working group members recommend that information on all SOCs be reported (except “social circumstances”) for any new anti-OA drug that does not pertain to any of the categories listed above. Specific SOC lists will be issued by the ESCEO for each future new drug, at the appropriate time

ASU avocado soybean unsaponifiable, COX cyclooxygenase, ESCEO European Society for Clinical and Economic Aspects of Osteoporosis Osteoarthritis and Musculoskeletal Diseases, HA hyaluronic acid, MedDRA Medical Dictionary for Regulatory Activities, NSAID non-steroidal anti-inflammatory drug, OA osteoarthritis, PRP platelet-rich plasma, SOC system organ class, SYSADOA symptomatic slow-acting drugs for OA