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1861 patients screened 1688 with tumors suitable for EGFR expression assessment. 321 excluded 183 did not meet inclusion criteria 79 refused to participate 59 other reasons. 1442 patients with EGFR-expressing tumors. 4 EGFR status unknown. 1125 randomly assigned ITT population.
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1861 patients screened 1688 with tumors suitable for EGFR expression assessment 321 excluded 183 did not meet inclusion criteria 79 refused to participate 59 other reasons 1442 patients with EGFR-expressing tumors 4 EGFR status unknown 1125 randomly assigned ITT population 557 allocated to chemotherapy plus cetuximab 548 given chemotherapy plus cetuximab 6 not given study treatment 3 given chemotherapy alone 568 allocated to chemotherapy alone 559 given chemotherapy 9 not given study treatment 543 discontinued study 372 progressive disease 74 died 15 withdrew consent 14 symptomatic deterioration 10 further anticancer treatment needed 56 other 2 lost to follow-up 563 discontinued study 350 progressive disease 58 died 13 withdrew consent 16 symptomatic deterioration 18 further anticancer treatment needed 100 other 8 lost to follow-up • 557 patients included in the ITT efficacy analysis • 555 assessed for EGFR expression • 482 assessed for EGFR mutation status • 481 assessed for both EGFR expression and EGFR • mutation status • 568 patients included in the ITT efficacy analysis • 566 assessed for EGFR expression • 489 assessed for EGFR mutation status • 489 assessed for both EGFR expression and EGFR • mutation status High EGFR expression 115 EGFR wild-type 25 EGFR mutant High EGFR expression 123 EGFR wild-type 25 EGFR mutant Low EGFR expression 307 EGFR wild-type 42 EGFR mutant Low EGFR expression 292 EGFR wild-type 41 EGFR mutant