Primary endpoint
NSCLC
DISEASE, RECURRENT DISEASE, LUNG CANCER, NSCLC, REGRESSION
Similar results were found in the ITT and PP populations for the primary endpoint; data reported here are for the ITT population. At data cutoff, all randomized patients had completed the week 18 visit or had been excluded from the disease evaluation period.In the ITT population, the ORROverall response rate, risk ratio and multivariate‐adjusted risk ratio, and risk difference and multivariate‐adjusted risk difference at week 18 – ITT population.Abbreviations: CI, confidential interval; CR, complete response; ITT, intention‐to‐treat; IWRS, interactive web response system; NSCLC, non‐small cell lung cancer; ORRThe ORRThe method of Clopper and Pearson was used to calculate CIs.The risk ratio was estimated including covariates of stratification factors: NSCLC stage (recurrent disease after any stage at time of primary diagnosis, or Stage IV), sex (male or female), and ethnicity (Asian or non‐Asian). Stratification factors were from an IWRS system.The multivariate‐adjusted risk ratio and the 90% CI were estimated by the log‐binomial regression model including stratification factors. Stratification factors were from an IWRS system.The risk difference was estimated including covariates of stratification factors: NSCLC stage (recurrent disease after any stage at time of primary diagnosis, or Stage IV), sex (male or female), and ethnicity (Asian or non‐Asian). Stratification factors were from an IWRS system.The multivariate‐adjusted risk difference and the 95% CI were estimated by the binomial regression model including stratification factors. Stratification factors were from an IWRS system.The ORRClinical equivalence of BAT1706 and EU‐bevacizumab was demonstrated using both the risk ratio and risk difference methods, regardless of the stratification factors, and was supported by the multivariate‐adjusted risk analyses (Table 