Inib (n 69) No. 64 30-83 58 42 88 6 3 1 1 32 62 six 58 29 9 0 four 86 14 67 33 51 45 4 62 19 19 71 ten 19 17 14 28 three 0 0 0 9 22 0 17 12 1 0 1 30 1 20 11 0 31 0 21 7 3 24 4 three MET Adverse Placebo Plus Erlotinib (n 31) No. 61 42-83 55 45 90 10 0 0 0 29 71 0 55 39 three 0 3 97 3 65 35 0 100 0 68 23 10 77 13 ten 20 11 27 three 0 0 1 8 20 3 12 14 4 0 1 29 two 21 ten 0 31 0 19 six 6 25 0 six Onartuzumab Plus Erlotinib (n 31) No. 63 45-82 65 35 87 10 0 0 three 26 65 ten 39 45 13 0 3 93 7 68 32 0 100 0 61 19 19 81 0 19 20 11 28 1 1 0 1 10 19 2 21 five 2 1 2 25 6 22 9 31 0 0 20 six five 24 two 5 MET Constructive Placebo Plus Erlotinib (n 31) No. 64 44-82 65 35 90 3 3 0 3 32 61 six 68 16 six three six 81 19 71 29 100 0 0 65 19 16 77 7 16 18 17 32 1 1 1 0 13 21 1 26 5 2 0 2 28 7 22 13 35 0 0 24 7 four 24 7 four Onartuzumab Plus Erlotinib (n 35) No. 66 30-83 51 49 91 3 three three 0 37 60 three 74 14 6 0 six 80 20 63 37 one hundred 0 0 69 20 11 69 20 11Abbreviations: ECOG PS, Eastern Cooperative Oncology Group overall performance status; IHC, immunohistochemistry; ITT, intent to treat. Because of rounding, some percentages don’t sum to 100. Never-smokers defined as individuals who had under no circumstances smoked or smoked 100 cigarettes in lifetime.www.jco.org2013 by American Society of Clinical OncologySpigel et almonths, corresponding to a hazard ratio (HR) of 0.six. The kind I (two-sided) and II error prices had been set as 10 and 50 , respectively. Further objectives integrated assessment of OS, ORR, safety, and tolerability. All outcomes had been assessed within the ITT and MET diagnostic groups. Median PFS and OS have been estimated from Kaplan-Meier curves. Stratifiedlog-rank test was applied to test the difference in PFS and OS amongst therapy arms. Estimated HRs and 95 CIs were determined making use of a stratified Cox regression model. All authors reviewed the information and manuscript and vouch for the accuracy, completeness, and fidelity of this report to the study protocol.A1.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) HR 95 CI Log-rank P No. of events two.6 two.two 1.09 .73 to 1.62 .69 56B1.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) HR 95 CI Log-rank P No.H-Leu-OMe.HCl site of events 1.5 0.53 .283 to .99 .04 two.Progression-Free Survival (probability)0.8 0.6 0.four 0.Progression-Free Survival (probability)0.eight 0.6 0.four 0.Time (months)Placebo + erlotinib Onartuzumab + erlotinib 68 69 20 17 12 12 three 2 1 2 0 1 0 0 Placebo + erlotinib Onartuzumab + erlotinib 31 35 4Time (months)two 9 2 two 1 two 0 1 0C1.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) HR 95 CI Log-rank P No. of events 2.7 1.four 1.82 .99 to 3.32 .D1.0 0.8 0.6 0.four 0.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) HR 95 CI Log-rank P No.2-Hexyloctanoic acid Purity of events 7.PMID:23460641 four 8.9 0.80 0.50 to 1.28 .34 41Progression-Free Survivla (probability)0.six 0.four 0.General Survival (probability)0.Time (months)Placebo + erlotinib Onartuzumab + erlotinib 31 31 13 6 9 3 1 0 0 0 0 0 0 0 Placebo + erlotinib Onartuzumab + erlotinib 68 69 49 50 38Time (months)16 19 9 eight 3 two 0 1 0E1.0 0.8 0.6 0.four 0.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) HR 95 CI Log-rank P No. of events three.eight 12.6 0.37 .19 to .72 .002F1.0 0.eight 0.six 0.4 0.Placebo + Onartuzumab + Erlotinib Erlotinib Median (months) 15.three 8.1 HR 1.78 95 CI .79 to three.99 Log-rank P .16 No. of events 13Overall Survival (probability)General Survival (probability)Time (months)Placebo + erlotinib Onartuzumab + erlotinib 31 35 18 30 13 23 7 14 three 8 1 two 0 1 0 0 Placebo + erlotinib Onartuzumab + erlotinib 31 31 27Time (months)22 14 9 five six 0 2 0 0 0 0Fig 2. Kaplan-Meier estimate.