Table 5: Summary of AEs [Safety Dataset]

Safety Outcome Structum (N=411) Chondrosulf (N=424)
Number of AE 392 440
Number of TE AE 392 438
Number of Serious AE 5 15
Patients with at least one AE 177 (43.10) 191 (45.00)
Patients with at least one TE AE 177 (43.10) 190 (44.80)
Patients with at least one AE leading to definitive study drug discontinuation [1] 10 (2.40) 19 (4.50)
Patients with at least one AE leading to withdrawal [1] 10 (2.40) 19 (4.50)
Patients with at least one serious AE 5 (1.20) 14 (3.30)

[1] One patient discontinued the study follow-up on D47 due to an AE. He has not been discontinued from the study treatment.