| All-exposed population n= 4,009 | ||||
---|---|---|---|---|---|
 | Overall | ≤ 6 months | 7-12 months | 13-18 months | > 18 months |
Total duration, PY | 9,414 | 1,805 | 1,664 | 1,542 | 4,404 |
AEs, rate/100 PY | |||||
   Anya | 278.2 | 441.1 | 340.4 | 284.7 | 245.5 |
   Severea, b | 18.0 | 24.0 | 20.7 | 17.3 | 15.3 |
   Treatment relateda, c | 112.8 | 214.7 | 141.0 | 106.4 | 85.2 |
   Led to withdrawala | 5.8 | 11.5 | 6.7 | 4.9 | 3.5 |
Led to dose modification/ interruptiona | 36.6 | 41.3 | 40.2 | 37.3 | 37.8 |
SAEs, rate/100 PY | |||||
   Anya | 14.4 | 15.9 | 15.1 | 13.9 | 14.0 |
   Treatment relatedc | 5.0 | 6.0 | 5.1 | 4.0 | 4.9 |