Deviations from the nominal time will be given in a separate listing for each compound. •a summary of concentrations for each compound by cohort and nominal time, where the set of statistics will include n, mean, standard deviation, median, coefficient of CCI Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 22variation (cv), minimum, maximum and the number of concentrations above the lower limit of quantification. for the concentration -time data after the first dose median concentrations time plots (on both linear and semi -log scales) against nominal time post dose by cohort (all cohorts on the same plot per scale, based on the summary of concentrations by cohort and time postdose) for tremelimumab (for Cohorts 3A and 4A onl y) and PF - 06801591 (for Cohorts 6A through 9A). for the concentration -time data after the first dose mean concentrations time plots (on both linear and semi- log scales) against nominal time postdose by cohort (all cohorts on the same plot per scale, based on the summary of concentrations by cohort and time postdose) for tremelimumab (for Cohor ts 3A and 4A only ) and PF -06801591 (for Cohorts 6A through 9A). For drug concentration summary statistics, median and mean plots by sampling time, the nominal PK sampling time will be used. Calculation of tremelimumab PK parameters For patients of Cohorts 3A and 4 A, the concentration- time data of tremelimumab after the first dose will be analyzed individually by non -compartmental methods to determine the PK parameters. For patients of Cohorts 6A through 9A, the concentration time data of PF-06801591 after the first dose will be anal yzed individually by non compartmental methods to determine the PK parameters. For each compound, the PK parameters to be estimated will include the maximum drug concentration (C max), time to maximum drug concentration (T max), and area under the concentration versus time curve (AUC) from time zero to the last quantifiable time point prior to the second tremelimumab or PF -06801591 dose (AUC last), and if data permit, AUC from time zero extrapolated to infinity (AUC inf), terminal elimination half -life (t 1/2), and apparent clearance (CL/F). In addition, the accumulation ratio (Rac) as calculated by the ratio of the trough concentration prior to the fifth tremelimumab or PF -06801591 dose (on Cycle 2 Day 1) to the concent ration prior to the second tremelimumab or PF -06801591 dose (on Cycle 1, Day 29) will be determined individually if data permit. PK parameters will be calculated using standard non- compartmental methods: Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 23Parameter Method of Determination AUC last Linear/log trapezoidal method AUC infaAUC last+ (C last*/k el), where C last* is the predicted concentration at the last quantifiable time point (T) estimated from the log-linear regression analysis, and k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The terminal log-linear phase will be determined from a minimum of 3 concentration-time data points, and will be verified with the r2 value. Cmax Observed directly from data CL/FaDose/AUC inf t½aln2/k el Tmax Observed directly from data aif data permit. The PK parameters of each compound will be summarized as below: Parameter Summary statistics AUClast, AUC inf, Cmax, and CL/FN, arithmetic mean, median, cv%, standard deviation, minimum, maximum, geometric mean. t1/2 N, arithmetic mean, median, cv%, standard deviation, minimum, maximum.