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. Author manuscript; available in PMC: 2019 Dec 3.
Published in final edited form as: J Thorac Oncol. 2017 Jul 6;12(10):1552–1560. doi: 10.1016/j.jtho.2017.06.070

Table 4.

AEs Leading to Dose Modification, Interruption, or Withdrawal in the Pooled Studies (ITT Population)

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.