. . which artbin c:\ian\git\artbin\package\artbin.ado *!version 2.1.0 IW 04jan2024 . which art2bin c:\ian\git\artbin\package\art2bin.ado *!version 1.01 09june2022 . . ********************************************* . ********************************************* . * Testing: Comparing to Cytel's East package . ******************************************** . ********************************************* . . // 1 // . artbin, pr(0.1 0.1) margin(0.2) alpha(0.1) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize1 = r(n) . . if `samplesize1'!=78 { . di as err "Sample size does not match with EAST. Should be n = 78" . exit 198 . } . . // 2 // . artbin, pr(0.3 0.3) margin(0.1) alpha(0.05) power(0.8) wald 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) 0.800 Total sample size (calculated) 660 Sample size per group (calculated) 330 330 Expected total number of events 198 Expected number of events per group 99 99 ------------------------------------------------------------------------------ . local samplesize2 = r(n) . . if `samplesize2'!=660 { . di as err "Sample size does not match with EAST. Should be n = 660" . exit 198 . } . . // 3 // . artbin, pr(0.3 0.3) margin(0.05) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize3 = r(n) . . if `samplesize3'!=3532 { . di as err "Sample size does not match with EAST. Should be n = 3532" . exit 198 . } . . // 4 // . artbin, pr(0.15 0.15) margin(0.15) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize4 = r(n) . . if `samplesize4'!=240 { . di as err "Sample size does not match with EAST. Should be n = 240" . exit 198 . } . . // 5 // . artbin, pr(0.2 0.2) margin(0.1) alpha(0.2) power(0.8) wald 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 ------------------------------------------------------------------------------ . local samplesize5 = r(n) . . if `samplesize5'!=290 { . di as err "Sample size does not match with EAST. Should be n = 290" . exit 198 . } . . // 6 // . artbin, pr(0.1 0.1) margin(0.05) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize6 = r(n) . . if `samplesize6'!=1514 { . di as err "Sample size does not match with EAST. Should be n = 1514" . exit 198 . } . . // 7 // . artbin, pr(0.25 0.25) margin(0.2) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize7 = r(n) . . if `samplesize7'!=198 { . di as err "Sample size does not match with EAST. Should be n = 198" . exit 198 . } . . // 8 // . artbin, pr(0.2 0.2) margin(0.15) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize8 = r(n) . . if `samplesize8'!=300 { . di as err "Sample size does not match with EAST. Should be n = 300" . exit 198 . } . . // 9 // . artbin, pr(0.15 0.15) margin(0.05) alpha(0.05) power(0.9) wald 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 ------------------------------------------------------------------------------ . local samplesize9 = r(n) . . if `samplesize9'!=2144 { . di as err "Sample size does not match with EAST. Should be n = 2144" . exit 198 . } . . // 10 // . artbin, pr(0.9 0.9) margin(-0.023) alpha(0.05) power(0.9) wald ar(1 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 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 <= -.023 Alternative hypothesis H1: pi2 - pi1 > -.023 Anticipated event probabilities 0.900 0.900 Alpha 0.050 (two-sided) (taken as .025 one-sided) Power (designed) 0.900 Total sample size (calculated) 8045 Sample size per group (calculated) 2682 5363 Expected total number of events 7240.5 Expected number of events per group 2413.8 4826.7 ------------------------------------------------------------------------------ . local samplesize10 = r(n) . . if `samplesize10'!=8045 { . di as err "Sample size does not match with EAST. Should be n = 8045" . exit 198 . } . . // REPORT SUCCESS . di as result _n "*************************************************************" /// > _n "*** ARTBIN HAS PASSED ALL SOFTWARE TESTING POINT 5 **********" /// > _n "*************************************************************" ************************************************************* *** ARTBIN HAS PASSED ALL SOFTWARE TESTING POINT 5 ********** ************************************************************* . . . log close