Table 4 Adverse events observed in the safety population
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) |