Overall Survival Cox-regression Analyses of Phase III trials: IL0014 and IL0017 in First Line NSCLC Patients

*In all the models Treatment = 0 =Placebo and Treatment =1 = ZD1839

 

Overall Survival Study IL0014 - FDA Analysis (250 mg vs. Placebo)

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.07086 0.09141 0.6009 0.4382 1.073 0.897 1.284

Overall Survival Study IL0014 - FDA Analysis (500 mg vs. Placebo)

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.09350 0.09097 1.0563 0.3041 1.098 0.919 1.312

Overall Survival Study IL0014 - FDA Analysis (250mg + 500mg ZD1839 vs. Placebo)

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.08291 0.07922 1.0952 0.2953 1.086 0.930 1.269

 

Overall Survival Study IL0017 - FDA Analysis (250 mg vs. Placebo)

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.04177 0.09010 0.2150 0.6429 1.043 0.874 1.244

Overall Survival Study IL0017 - FDA Analysis (500 mg vs. Placebo)

 

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 -0.03885 0.09147 0.1804 0.6710 0.962 0.804 1.151

Overall Survival Study IL0017 - FDA Analysis (250mg + 500mg ZD1839 vs. Placebo)

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.00143 0.07838 0.0003 0.9855 1.001 0.859 1.168

 

 

 

 

 

 

 

 

 

 

Studies Combined - Overall Survival FDA Analysis (250 mg vs. Placebo stratified by study )

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.05730 0.06426 0.7949 0.3726 1.059 0.934 1.201

Studies Combined - Overall Survival FDA Analysis (500 mg vs. Placebo stratified by study)

 

Parameter Standard Hazard 95% Hazard Ratio

Variable DF Estimate Error Chi-Square Pr > ChiSq Ratio Confidence Limits

Treatment 1 0.02458 0.06461 0.1447 0.7036 1.025 0.903 1.163