Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 168.1.2.2. Analysis of Secondary Safety Endpoints These safet y endpoints will be analyzed according to the Pfizer Data Standard. To better characterize the safet y profile of the different regimen components anal yses of safet y will be cond ucted b y cohort, by cycle ( i.e., C ycle 1,2, maintenance cy cle) and by period (Day 1 to Day 28, Day 29 to Day 85). Laboratory Tests Abnormalities The number and percentage of patients who experienced laboratory test abnormalities will be summarized according to worst toxicity grade observed for each lab assay. The analyses will summarize laboratory tests by cohort and visit. The most recent measure ment prior to dosing is considered as baseline. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, abnormal or not done . ECG The analysis of ECG results will be based on patients in the safety analysis set with baseline and on -treatment ECG data. Baseline is defined as the pre -dose ECG collected before the first dose of any component of the study treatment. ECG measurements (an average of the triplicate measurements) will be used for the statistical analysis and all data presentations. Any data obtained from ECGs repeated for safety reasons after the nominal time- points will not be averaged along with the preceding triplicates. Interval measurements from repeated ECGs will be included in the outlier analysis (categorical analysis) as individual values obtained at unscheduled time points. QT intervals will be corrected for heart rate (QTc) using standard correction factors (ie,Frederica’s). Data will be summarized and listed for QT, HR,PR, QRS, and QTcF by cohort. Individual QT intervals will be listed by time and cohort. Descriptive statistics (n,mean, median, standard deviation, minimum, and maximum) will be used to summarize the absolute corrected QT interval and changes from baseline in corrected QT a fter treatment by cohort and time point. For each patient and by treatment, the maximum change from baseline will be calculated as well as the maximum post- baseline interval across time-points. Categorical analysis will be conducted for the maximum chang e from baseline in corrected QT and the maximum post -baseline QT interval. Shift tables will be provided for baseline vs worst on treatment corrected QT. If applicable, the effect of relevant drug concentrations on corrected QT change from baseline will be explored graphically. Additional concentration -corrected QT analyses may be performed. Data may be pooled with other study results and/or explored further with PK/PD models.