Her’s precise test (sex, organomegaly). P-value from Pearson’s chi-square
Her’s exact test (sex, organomegaly). P-value from Pearson’s chi-square test for Hasford risk category and performance status. Unknowns had been excluded from significance tests. Pts=patients.NIH-PA Author ManuscriptPageNIH-PA Author ManuscriptNIH-PA Author ManuscriptBr J Haematol. Author manuscript; available in PMC 2015 January 01.TableTreatment outcomes of 145 CML-CP patients by therapy arm.IM400 (N=72) Pts 59 63 4 5 N=49 33 N=45 N=53 67 520 35 85 714 0.040 N=41 7 4 five six 24 3 4 12 0.49 88 784 66 90 816 0.38 82 710 62 85 752 0.40 95 CI Pts 95 CI P IM800 (N = 73)Full haematologic CCR4 Source response (confirmed)Total haematologic response (any)Resistant diseaseNot evaluableComplete cytogenetic responseMolecular response at 1 year : 16 four 4 9 21 ten 19 92 0.13 9 21 14 26 150 0.023 36 221 28 53 397 0.3-log decrease (MMR)4-log reduce(MR4.0)4.5-log decrease(MR4.5)One-sided p-value from Fisher’s precise test for superior outcome in the IM800 arm.Br J Haematol. Author manuscript; offered in PMC 2015 January 01.According to blood specimens collected 29506 days soon after randomization (if a patient’s molecular response was tested far more than when for the duration of that interval, only the result obtained closest to day 365 was integrated within this evaluation).NIH-PA Author ManuscriptDeininger et al. PageNIH-PA Author ManuscriptNIH-PA Author ManuscriptTableTreatment outcomes of 111 sufferers with CML-CP based on molecular response at 3 monthsIM400 ten (N=19) Pts 18 0 N=15 six N=10 1 0 0 0 01 3 11 29 0.38 0 0 04 10 29 156 0 01 three 11 29 0.38 0 0 04 14 40 248 ten 05 11 41 221 0.080 0 0 04 26 74 576 0.0001 0.020 0.074 N=27 N=9 N=35 40 168 23 85 666 0.0038 three 50 128 25 93 769 0.031 N=27 N=6 N=28 3 1 1 95 7400 33 92 768 0.83 9 82 488 44 98 8800 0.095 95 CI Pts 95 CI P Pts 95 CI Pts 95 CI P 10 (N=36) 10 (N=11) 10 (N=45) IMCHRNot evaluableCCyRMR at 1 year3-log (MMR)4-log(MR4.0)4.5-log(MR4.5)One-sided p-value for poorer outcome in patients with 10 reduction in transcript at three months, based on Fisher’s exact test.Contains 84 CHRs (40 IM400, 44 IM800) achieved on or prior to collection of 3-month specimen.All CCyRs were accomplished following day 90 specimen collection, except one particular IM400 patient four with 10 Reduction.Br J Haematol. Author manuscript; accessible in PMC 2015 January 01.Depending on blood specimens collected 29506 days right after randomization (if a patient’s molecular response was tested much more than when for the duration of that interval, only the result obtained closest to day 365 was integrated in this analysis).NIH-PA Author ManuscriptDeininger et al. PageNIH-PA Author ManuscriptNIH-PA Author ManuscriptTableToxicities of 144 CML-CP individuals who received assigned therapy, by remedy armIM400 (N=72) All ACAT manufacturer grades Haematologic toxicities 47 (65 ) 23 (32 ) 1 ( 1 ) 24 (33 ) Fluid retention 42 (58 ) 0 ( 0 ) Gastrointestinal toxicities 28 (39 ) 36 (50 ) 11 (15 ) 11 (15 ) Other non-haematologic toxicities 47 (65 ) 33 (46 ) 19 (26 ) 9 (13 ) 3 ( four ) 0 ( 0 ) 7 (ten ) 0 ( 0 ) 0.14 1 ( 1 ) 9 (13 ) 1 ( 1 ) 0.49 1 ( 1 ) 36 (50 ) four ( 6 ) 0.0012 2 ( three ) 42 (58 ) 8 (11 ) 0.011 0 ( 0 ) 57 (79 ) 11 (15 ) 0.0006 0 ( 0 ) 16 (22 ) 0 ( 0 ) 0.16 1 ( 1 ) 20 (28 ) 0 ( 0 ) 0.036 2 ( 3 ) 42 (58 ) two ( three ) 0.043 1 ( 1 ) 40 (56 ) six ( eight ) 0.0088 0 ( 0 ) two ( three ) 0 ( 0 ) 0.25 three ( 4 ) 50 (69 ) 2 ( 3 ) 0.15 six ( eight ) 46 (64 ) 14 (19 ) 0.0001 1 ( 1 ) 1 ( 1 ) 1 ( 1 ) 0.75 8 (11 ) 33 (46 ) 12 (17 ) 0.043 five ( 7 ) 59 (82 ) 8 (11 ) 0.0067 Grade three All grades Grade 3 P I.
