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1 sponse Evaluation Criteria In Solid Tumors (version 1.1) in all randomly assigned patients.
2 Analysis was done by intention to treat for all randomly assigned patients.
3 treatment failure and overall survival were ascertained for all randomly assigned patients.
4 valuated long-term survival and poststudy CLL therapy among all randomly assigned patients.
6 ry efficacy end points were disease-free survival (DFS) for all randomly assigned patients and DFS for randomly assigned
7 The co-primary endpoints were overall survival in all randomly assigned patients and in a poor-prognosis subgro
8 ary analysis was done on the intention-to-treat population (all randomly assigned patients) and safety analyses were done
9 s were progression-free survival per independent review for all randomly assigned patients, and for all randomly assigned
10 y endpoints were overall survival and objective response in all randomly assigned patients assessed by intention-to-treat
12 endpoint was by modified intention to treat, which included all randomly assigned patients irrespective of treatment rece
13 ER status was available for 3,329 patients (95% of all randomly assigned patients), of whom 75% (n = 2,493) were
14 ived daclatasvir plus asunaprevir and 102 received placebo; all randomly assigned patients received the intended treatmen
15 , analysed in the modified intention-to-treat population of all randomly assigned patients that completed the MADRS asses
16 view committee assessed progression-free survival, based on all randomly assigned patients (the full analysis set).
26 alysed in the modified intention-to-treat population (mITT; all randomly assigned patients who had received at least one
28 protocol analysis set, whereas the safety analysis included all randomly assigned patients who received at least one dose
29 Efficacy and safety analyses were done with all randomly assigned patients who received at least one dose
30 endpoint was local-regional control at 2 years, analysed in all randomly assigned patients who received at least one dose
33 s) and safety analyses were done in the treated population (all randomly assigned patients who received at least one dose
34 s of treatment in the full analysis set, which consisted of all randomly assigned patients who received at least one dose
40 ependent review for all randomly assigned patients, and for all randomly assigned patients with KRAS wild-type tumours.
41 s were done in the intention-to-treat population, including all randomly assigned patients with uncommon EGFR mutations.
43 -cause mortality at 45 days in the per-protocol population (all randomly assigned patients without major protocol violati
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