Table 4.
Outcome, n (%) | NP28761 (n = 87) | NP28673 (n = 138) | Pooled Population (N = 225) |
---|---|---|---|
AE leading to withdrawal from study | 2 (2) | 12 (9) | 14 (6) |
AE leading to withdrawal from treatment | 2 (2) | 12 (9) | 14 (6) |
AE leading to dose modification or interruption | 37 (43) | 38 (28) | 75 (33) |
Serious AE leading to withdrawal from treatment | 1 (1) | 8 (6) | 9 (4) |
Serious AE leading to dose modification or interruption | 9 (10) | 13 (9) | 22 (10) |
Related AE leading to withdrawal from treatment | 2 (2) | 8 (6) | 10 (4) |
Related AE leading to dose modification or interruption | 24 (28) | 23 (17) | 47 (21) |
AE, adverse event; ITT, intent-to-treat.