Table 5

Target knee adverse events: safety population

Hylan G-F 20Placebo
N  =  123N  =  130
Preferred termn (% of patients)n (% of patients)
Any treatment-emergent target knee AE44 (35.8)44 (33.8)
Any treatment and/or procedure-related target knee AE7 (5.7)4 (3.1)
    Arthralgia2 (1.6)3 (2.3)
    Joint effusion2 (1.6)0 (0)
    Arthritis1* (0.8)0 (0)
    Arthropathy1 (0.8)0 (0)
    Injection site pain1 (0.8)1 (0.8)
Any treatment-related target knee AE4 (3.3)1 (0.8)
Any procedure-related target knee AE6 (4.9)4 (3.1)
  • Related to treatment refers to unknown relationship to, or possibly, probably, or definitely related to treatment. Patients are counted once for each unique adverse event (AE) and may have had more than one unique AE. If a patient had more than one occurrence of the same AE, the strongest relationship to study treatment or injection procedure was included. Treatment groups reflect the actual treatment received, not the randomised treatment. Patients may be counted in more than one category. *Patient withdrew from the study due to target knee arthritis of moderate severity.