c:\ian\git\artbin\package\artbin.ado *!version 2.1.0 IW 04jan2024 c:\ian\git\artbin\package\art2bin.ado *!version 1.01 09june2022 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Anticipated event probabilities 0.100 0.100 Alpha 0.100 (two-sided) (taken as .05 one-sided) Power (designed) 0.900 Total sample size (calculated) 78 Sample size per group (calculated) 39 39 Expected total number of events 7.8 Expected number of events per group 3.9 3.9 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.300 0.300 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 3532 Sample size per group (calculated) 1766 1766 Expected total number of events 1059.6 Expected number of events per group 529.8 529.8 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Anticipated event probabilities 0.150 0.150 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 240 Sample size per group (calculated) 120 120 Expected total number of events 36 Expected number of events per group 18 18 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Anticipated event probabilities 0.200 0.200 Alpha 0.200 (two-sided) (taken as .1 one-sided) Power (designed) 0.800 Total sample size (calculated) 290 Sample size per group (calculated) 145 145 Expected total number of events 58 Expected number of events per group 29 29 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.100 0.100 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 1514 Sample size per group (calculated) 757 757 Expected total number of events 151.4 Expected number of events per group 75.7 75.7 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Anticipated event probabilities 0.250 0.250 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 198 Sample size per group (calculated) 99 99 Expected total number of events 49.5 Expected number of events per group 24.75 24.75 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Anticipated event probabilities 0.200 0.200 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 300 Sample size per group (calculated) 150 150 Expected total number of events 60 Expected number of events per group 30 30 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.150 0.150 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 2144 Sample size per group (calculated) 1072 1072 Expected total number of events 321.6 Expected number of events per group 160.8 160.8 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.9000 alpha = 0.0500 (one-sided) pi = 0.0500 delta = 0.0500 estimated required sample size (per group) = 326 The total estimated sample size is 652 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.050 0.050 Alpha 0.100 (two-sided) (taken as .05 one-sided) Power (designed) 0.900 Total sample size (calculated) 652 Sample size per group (calculated) 326 326 Expected total number of events 32.6 Expected number of events per group 16.3 16.3 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.8000 alpha = 0.0500 (one-sided) pi = 0.2000 delta = 0.1000 estimated required sample size (per group) = 198 The total estimated sample size is 396 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Anticipated event probabilities 0.200 0.200 Alpha 0.100 (two-sided) (taken as .05 one-sided) Power (designed) 0.800 Total sample size (calculated) 396 Sample size per group (calculated) 198 198 Expected total number of events 79.2 Expected number of events per group 39.6 39.6 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.7000 alpha = 0.0250 (one-sided) pi = 0.3000 delta = 0.1000 estimated required sample size (per group) = 260 The total estimated sample size is 520 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Anticipated event probabilities 0.300 0.300 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.700 Total sample size (calculated) 520 Sample size per group (calculated) 260 260 Expected total number of events 156 Expected number of events per group 78 78 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.9000 alpha = 0.0250 (one-sided) pi = 0.5000 delta = 0.3000 estimated required sample size (per group) = 59 The total estimated sample size is 118 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .3 Alternative hypothesis H1: pi2 - pi1 < .3 Anticipated event probabilities 0.500 0.500 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 118 Sample size per group (calculated) 59 59 Expected total number of events 59 Expected number of events per group 29.5 29.5 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.8000 alpha = 0.0500 (one-sided) pi = 0.6000 delta = 0.0500 estimated required sample size (per group) = 1188 The total estimated sample size is 2376 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.600 0.600 Alpha 0.100 (two-sided) (taken as .05 one-sided) Power (designed) 0.800 Total sample size (calculated) 2376 Sample size per group (calculated) 1188 1188 Expected total number of events 1425.6 Expected number of events per group 712.8 712.8 ------------------------------------------------------------------------------ Estimated sample size for two-sample comparison of proportions (non-inferiority) Null hypothesis: p2 - p1 ³ delta (inferior), where: pi (entered in command) is the overall proportion of participants expected to experience the outcome if the treatments are non-inferior, and delta is the smallest change in proportions between groups (p2 - p1) which would still be clinically important. Alternative hypothesis: p2 - p1 < delta (non-inferior) Note: a non-inferiority analysis is one-sided. Assumptions: power = 0.7000 alpha = 0.0250 (one-sided) pi = 0.8000 delta = 0.1000 estimated required sample size (per group) = 198 The total estimated sample size is 396 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Anticipated event probabilities 0.800 0.800 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.700 Total sample size (calculated) 396 Sample size per group (calculated) 198 198 Expected total number of events 316.8 Expected number of events per group 158.4 158.4 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Anticipated event probabilities 0.100 0.100 Alpha 0.100 (two-sided) (taken as .05 one-sided) Power (calculated) 0.903 Total sample size (designed) 78 Sample size per group (designed) 39 39 Expected total number of events 7.8 Expected number of events per group 3.9 3.9 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.300 0.300 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.900 Total sample size (designed) 3532 Sample size per group (designed) 1766 1766 Expected total number of events 1059.6 Expected number of events per group 529.8 529.8 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Anticipated event probabilities 0.150 0.150 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.902 Total sample size (designed) 240 Sample size per group (designed) 120 120 Expected total number of events 36 Expected number of events per group 18 18 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Anticipated event probabilities 0.200 0.200 Alpha 0.200 (two-sided) (taken as .1 one-sided) Power (calculated) 0.802 Total sample size (designed) 290 Sample size per group (designed) 145 145 Expected total number of events 58 Expected number of events per group 29 29 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.100 0.100 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.900 Total sample size (designed) 1514 Sample size per group (designed) 757 757 Expected total number of events 151.4 Expected number of events per group 75.7 75.7 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Anticipated event probabilities 0.250 0.250 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.901 Total sample size (designed) 198 Sample size per group (designed) 99 99 Expected total number of events 49.5 Expected number of events per group 24.75 24.75 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Anticipated event probabilities 0.200 0.200 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.901 Total sample size (designed) 300 Sample size per group (designed) 150 150 Expected total number of events 60 Expected number of events per group 30 30 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Anticipated event probabilities 0.150 0.150 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (calculated) 0.900 Total sample size (designed) 2144 Sample size per group (designed) 1072 1072 Expected total number of events 321.6 Expected number of events per group 160.8 160.8 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial substantial-superiority Number of groups 2 Favourable/unfavourable outcome favourable Inferred by the program Allocation ratio 1:3 Statistical test assumed unconditional comparison of 2 binomial proportions using the score test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 <= .15 Alternative hypothesis H1: pi2 - pi1 > .15 Anticipated event probabilities 0.200 0.500 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.800 Total sample size (calculated) 391 Sample size per group (calculated) 98 293 Expected total number of events 166.1 Expected number of events per group 19.6 146.5 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.7 p2 = 0.9 delta = 0.2 alpha = .025 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 20 Group 2: 20 Total: 40 Sample size using maximum likelihood estimation (more accurate): Group 1: 23 Group 2: 23 Total: 46 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Algorithm used 2-arm Anticipated event probabilities 0.300 0.100 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 40 Sample size per group (calculated) 20 20 Expected total number of events 8 Expected number of events per group 6 2 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.75 p2 = 0.85 delta = 0.1 alpha = .025 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 83 Group 2: 83 Total: 166 Sample size using maximum likelihood estimation (more accurate): Group 1: 86 Group 2: 86 Total: 172 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Algorithm used 2-arm Anticipated event probabilities 0.250 0.150 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 166 Sample size per group (calculated) 83 83 Expected total number of events 33.2 Expected number of events per group 20.75 12.45 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.8 p2 = 0.7 delta = 0.15 alpha = .05 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 1268 Group 2: 1268 Total: 2536 Sample size using maximum likelihood estimation (more accurate): Group 1: 1265 Group 2: 1265 Total: 2530 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Algorithm used 2-arm Anticipated event probabilities 0.200 0.300 Alpha 0.050 (one-sided) Power (designed) 0.900 Total sample size (calculated) 2536 Sample size per group (calculated) 1268 1268 Expected total number of events 634 Expected number of events per group 253.6 380.4 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.85 p2 = 0.8 delta = 0.1 alpha = .025 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 1209 Group 2: 1209 Total: 2418 Sample size using maximum likelihood estimation (more accurate): Group 1: 1217 Group 2: 1217 Total: 2434 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Algorithm used 2-arm Anticipated event probabilities 0.150 0.200 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 2418 Sample size per group (calculated) 1209 1209 Expected total number of events 423.15 Expected number of events per group 181.35 241.8 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.9 p2 = 0.9 delta = 0.05 alpha = .05 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 617 Group 2: 617 Total: 1234 Sample size using maximum likelihood estimation (more accurate): Group 1: 631 Group 2: 631 Total: 1262 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Algorithm used 2-arm Anticipated event probabilities 0.100 0.100 Alpha 0.050 (one-sided) Power (designed) 0.900 Total sample size (calculated) 1234 Sample size per group (calculated) 617 617 Expected total number of events 123.4 Expected number of events per group 61.7 61.7 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.7 p2 = 0.75 delta = 0.15 alpha = .025 (one-sided) power = .9 allocation = 1:1 not assessable = 0 Sample size using observed values (approximate): Group 1: 105 Group 2: 105 Total: 210 Sample size using maximum likelihood estimation (more accurate): Group 1: 105 Group 2: 105 Total: 210 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio equal group sizes Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Algorithm used 2-arm Anticipated event probabilities 0.300 0.250 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 210 Sample size per group (calculated) 105 105 Expected total number of events 57.75 Expected number of events per group 31.5 26.25 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.7 p2 = 0.9 delta = 0.2 alpha = .025 (one-sided) power = .9 allocation = 1:2 not assessable = 0 Sample size using observed values (approximate): Group 1: 17 Group 2: 34 Total: 51 Sample size using maximum likelihood estimation (more accurate): Group 1: 15 Group 2: 30 Total: 45 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:2 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .2 Alternative hypothesis H1: pi2 - pi1 < .2 Algorithm used 2-arm Anticipated event probabilities 0.300 0.100 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 51 Sample size per group (calculated) 17 34 Expected total number of events 8.5 Expected number of events per group 5.1 3.4 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.75 p2 = 0.85 delta = 0.1 alpha = .025 (one-sided) power = .9 allocation = 1:3 not assessable = 0 Sample size using observed values (approximate): Group 1: 61 Group 2: 182 Total: 243 Sample size using maximum likelihood estimation (more accurate): Group 1: 50 Group 2: 149 Total: 199 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:3 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Algorithm used 2-arm Anticipated event probabilities 0.250 0.150 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 243 Sample size per group (calculated) 61 182 Expected total number of events 42.55 Expected number of events per group 15.25 27.3 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.8 p2 = 0.7 delta = 0.15 alpha = .05 (one-sided) power = .9 allocation = 1:4 not assessable = 0 Sample size using observed values (approximate): Group 1: 728 Group 2: 2912 Total: 3640 Sample size using maximum likelihood estimation (more accurate): Group 1: 687 Group 2: 2745 Total: 3432 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:4 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Algorithm used 2-arm Anticipated event probabilities 0.200 0.300 Alpha 0.050 (one-sided) Power (designed) 0.900 Total sample size (calculated) 3640 Sample size per group (calculated) 728 2912 Expected total number of events 1019.2 Expected number of events per group 145.6 873.6 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.85 p2 = 0.8 delta = 0.1 alpha = .025 (one-sided) power = .9 allocation = 1:2 not assessable = 0 Sample size using observed values (approximate): Group 1: 873 Group 2: 1745 Total: 2618 Sample size using maximum likelihood estimation (more accurate): Group 1: 838 Group 2: 1675 Total: 2513 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:2 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Algorithm used 2-arm Anticipated event probabilities 0.150 0.200 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 2618 Sample size per group (calculated) 873 1745 Expected total number of events 479.95 Expected number of events per group 130.95 349 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.9 p2 = 0.9 delta = 0.05 alpha = .05 (one-sided) power = .9 allocation = 1:4 not assessable = 0 Sample size using observed values (approximate): Group 1: 386 Group 2: 1542 Total: 1928 Sample size using maximum likelihood estimation (more accurate): Group 1: 333 Group 2: 1332 Total: 1665 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:4 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Algorithm used 2-arm Anticipated event probabilities 0.100 0.100 Alpha 0.050 (one-sided) Power (designed) 0.900 Total sample size (calculated) 1928 Sample size per group (calculated) 386 1542 Expected total number of events 192.8 Expected number of events per group 38.6 154.2 ------------------------------------------------------------------------------ +----------------------------------------------------------------------------+ | Sample size calculation for non-inferiority trials using a risk difference | +----------------------------------------------------------------------------+ p1 = 0.7 p2 = 0.75 delta = 0.15 alpha = .025 (one-sided) power = .9 allocation = 1:3 not assessable = 0 Sample size using observed values (approximate): Group 1: 72 Group 2: 215 Total: 287 Sample size using maximum likelihood estimation (more accurate): Group 1: 62 Group 2: 186 Total: 248 ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome unfavourable Inferred by the program Allocation ratio 1:3 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 >= .15 Alternative hypothesis H1: pi2 - pi1 < .15 Algorithm used 2-arm Anticipated event probabilities 0.300 0.250 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 287 Sample size per group (calculated) 72 215 Expected total number of events 75.35 Expected number of events per group 21.6 53.75 ------------------------------------------------------------------------------ ART - ANALYSIS OF RESOURCES FOR TRIALS (binary version 2.1.0 04jan2024) ------------------------------------------------------------------------------ A sample size program by Abdel Babiker, Patrick Royston, Friederike Barthel, Ella Marley-Zagar and Ian White MRC Clinical Trials Unit at UCL, London WC1V 6LJ, UK. ------------------------------------------------------------------------------ Type of trial non-inferiority Number of groups 2 Favourable/unfavourable outcome favourable Inferred by the program Allocation ratio 1:2 Statistical test assumed unconditional comparison of 2 binomial proportions using the wald test Local or distant distant Continuity correction no Null hypothesis H0: pi2 - pi1 <= -.1 Alternative hypothesis H1: pi2 - pi1 > -.1 Anticipated event probabilities 0.700 0.750 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.800 Loss to follow up assumed 20 % Total sample size (calculated) 398 Sample size per group (calculated) 133 265 Expected total number of events 233.48 Expected number of events per group 74.48 159 ------------------------------------------------------------------------------ ************************************************************* *** ARTBIN HAS PASSED ALL SOFTWARE TESTING POINT 1 ********* *************************************************************