Table 3 Summary of adverse events and discontinuations over time in the total population
|  | Month | Post-month 48 (n = 99) | |||||||
|---|---|---|---|---|---|---|---|---|---|
0–6 | 6–12 | 12–18 | 18–24 | 24–30 | 30–36 | 36–42 | 42–48 | ||
(n = 486) | (n = 455) | (n = 430) | (n = 405) | (n = 343) | (n = 309) | (n = 293) | (n = 207) | ||
Adverse events | 379 (78.0) | 310 (68.1) | 254 (59.1) | 215 (53.1) | 178 (51.9) | 170 (55.0) | 145 (49.5) | 80 (38.6) | 58 (58.6) |
Discontinuations due to adverse events | 26 (5.3) | 19 (4.2) | 21 (4.9) | 7 (1.7) | 13 (3.8) | 8 (2.6) | 12 (4.1) | 1 (0.5) | 7 (7.1) |
Discontinuations due to serious adverse events | 15 (3.1) | 16 (3.5) | 10 (2.3) | 7 (1.7) | 6 (1.7) | 6 (1.9) | 8 (2.7) | 1 (0.5) | 6 (6.1) |
Discontinuations due to serious infection events | 6 (1.2) | 7 (1.5) | 4 (0.9) | 4 (1.0) | 3 (0.9) | 3 (1.0) | 5 (1.7) | 0 (0.0) | 3 (3.0) |