Table 22. Datasets for Studies 1001, 1005, 1007, 1014 Study 1001 ALK-positive NSCLC 1005 Study 1007 Study 1014 subset of study only 60 day 120 60 day 120 day 60 day 120 day CSR update day CSR update update update update update CER 1 1 2 1 1 2 1 2 2 Number in 119a 136b 149 136a 261b 439 71 116 19 safety (mature population safety population 261) Key efficacy RE RE RE n=76 RE RE n=259 populations n=116 n=143 n=133 See note ‘d’ First visit 7.1.2010 Cut-off 1.6.2011 1.2.2011 Comment Updated Information Information safetyc and on SAEs on on SAEs safety on safety safety on efficacyd and deaths SAEs data SAEs and data SAEs data only and efficacy and deaths data deaths only only
Table 22. Datasets for Studies 1001, 1005, 1007, 1014 Study 1001 ALK-positive NSCLC subset of study only 1005 Study 1007 Study 1014 CSR 60 day update 120 day update CSR 60 day update 120 day update 60 day update 120 day update CER 1 1 2 1 1 2 1 2 2 Number in safety population 119a 136b 149 136a 261b 439 (mature safety population 261) 71 116 19 Key efficacy populations RE n=116 RE n=143 RE n=76 RE n=133 RE n=259 See note ‘d’ First visit 7.1.2010 Cut-off 1.6.2011 1.2.2011 Comment safety data on SAEs and deaths only safety and efficacy data safety data on SAEs and deaths only Updated safetyc and efficacyd data Information on SAEs and deaths only on SAEs Information on SAEs
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