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 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 ------------------------------------------------------------------------------ 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 ------------------------------------------------------------------------------ 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 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 3112 Sample size per group (calculated) 1556 1556 Expected total number of events 778 Expected number of events per group 311.2 466.8 ------------------------------------------------------------------------------ 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 >= .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 ------------------------------------------------------------------------------ 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 0.025 (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 >= .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 ------------------------------------------------------------------------------ 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 0.250 0.250 Alpha 0.025 (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 >= .05 Alternative hypothesis H1: pi2 - pi1 < .05 Algorithm used 2-arm Anticipated event probabilities 0.200 0.100 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 234 Sample size per group (calculated) 117 117 Expected total number of events 35.1 Expected number of events per group 23.4 11.7 ------------------------------------------------------------------------------ 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 >= .1 Alternative hypothesis H1: pi2 - pi1 < .1 Algorithm used 2-arm Anticipated event probabilities 0.150 0.150 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 536 Sample size per group (calculated) 268 268 Expected total number of events 80.4 Expected number of events per group 40.2 40.2 ------------------------------------------------------------------------------ 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 0.100 0.150 Alpha 0.025 (one-sided) Power (designed) 0.900 Total sample size (calculated) 1830 Sample size per group (calculated) 915 915 Expected total number of events 228.75 Expected number of events per group 91.5 137.25 ------------------------------------------------------------------------------ ************************************************************* *** ARTBIN HAS PASSED ALL SOFTWARE TESTING POINT 4 ********** *************************************************************