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Table 4 Adverse events observed in the safety population

From: Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial

Adverse events GS/CS (N = 314) RP (N = 312)
Patients reporting at least one AE, n (%) 195 (62.1) 202 (64.7)
Total AEs reported, n 504 572
Incidence of AEs considered related to the treatment, n (%) 67 (21.3) 85 (27.2)
Incidence of serious AEs, n (%) 3 (0.96) 2 (0.6)
Total of serious AEs, n 5 2
Incidence of AEs leading to treatment discontinuation, n (%) 9 (2.9) 8 (2.6)
AEs with incidence ≥ 5%
Arthralgia, n (%) 15 (4.8) 19 (6.1)
Myalgia, n (%) 10 (3.2) 18 (5.8)
Back pain, n (%) 30 (9.6) 27 (8.7)
Pain in the extremity, n (%) 20 (6.4) 23 (7.4)
Impaired glucose tolerance, n (%) 12 (3.8) 20 (6.4)
Headache, n (%) 45 (14.3) 49 (15.7)
Upper respiratory tract infection, n (%) 24 (7.6) 21 (6.7)
Nasopharyngitis, n (%) 13 (4.1) 19 (6.1)
Flu, n (%) 13 (4.1) 21 (6.7)
  1. P < 0.05 between groups for all descriptions. AE(s): adverse event(s); GS/CS: glucosamine sulfate/ chondroitin sulfate; n (%): number and percentage of patients with at least one AE reported in relation to the total number of patients in the safety population; RP: reference product