D CR plus PR. e Applying exact approach depending on F

at threat Japanese 44 Non-Japanese 169 42 128 38 117 33 103 33 97 31 84 30 72 27 65 26 61 21 51 11 47 10 45 five 38 0 21 0 9 0 six 0 1 0 0 0BProgression-free survival ( )one hundred 90 80 70 60 50 40 30 20 10 0 0 2 4 6 eight ten 12 14 16 18 20 22 JapanesenEvents mPFS, mo 95 CI 23 27.six 16.6?3.Time (months) No. at risk Japanese 44 42 38 33 33 31 30 27 26 24 22 21 20 16 eight 7 4 0Figure 4. Kaplan eier estimates of progression-free survival (PFS) in (A) Japanese vs. non-Japanese individuals at 12 October 2012 information cutoff, and (B) Japanese patients at 17 Might 2013 data cutoff. NE, not estimable.Jpn J Clin Oncol, 2016 , Vol. 46, No.Table five. Typical Pinometostat site treatment-emergent, all-causality AEs reported by all Japanese vs. non-Japanese sufferers AE, n ( )a Japanese n = 44 All-grade Hypertension Diarrhea Hand oot syndrome Dysphonia Hypothyroidism Proteinuria Decreased appetite Fatigue Stomatitis Nasopharyngitis Weight decreased Dysgeusia Nausea Alopecia Constipation Epistaxis Headache Vomiting Dyspnea Discomfort in extremity 40 (91) title= journal.pcbi.1005422 33 (75) 32 (73)b 30 (68)b 30 (68)b 27 (61)b 21 (48) 21 (48) 15 (34)b 14 (32)b 13 (30) 12 (27) 11 (25) 9 (20) 9 (20) 9 (20) 8 (18) four (9) 4 (9) three (7)bTable 6. Widespread treatment-emergent, all-causality AEs reported by Japanese patients in every treatment arm AE, n ( )a Axitinib titration n = six Allgrade Hypertension Diarrhea Hypothyroidism Hand oot syndrome Dysphonia Proteinuria Fatigue Decreased appetite Nasopharyngitis Stomatitis Alopecia Epistaxis Hyperuricemia Weight decreased Dysgeusia Headache NauseaaNon-Japanese n = 169 Grade 3/4 29 (66) 1 (2) six (14) 0 0 1 (2) three (7) two (five) 0 0 two (5) 0 1 (2) 0 0 0 0 0 1 (two)bPlacebo titration n = five Allgrade five (100) 5 (one hundred) three (60) 5 (one hundred) five (one hundred)c four (80)c 3 (60) three (60) 1 (20) two (40) 0 0 0 two (40) two (40) 1 (20)c 2 (40) Grade 3/4 2 (40) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0Non-randomized n = 32 Allgrade 29 (91) 23 (72) 22 (69) 22 (69) 21 (66) 20 (63) 15 (47) 13 (41) 12 (38) 11 (34) 9 (28) 8 (25) eight (25) 8 (25) 7 (22) 7 (22) 7 (22) Grade 3/4 23 (72) 1 (3) 0 5 (16) 0 0 two (six) 3 (9) 0 0 0 0 1 (three) 1 (3) 0 0 1 (3)All-grade 98 (58) 94 (56).D CR plus PR. e Applying precise method depending on F distribution.Table 4. Tumor shrinkage in Japanese vs. non-Japanese patients Japanese Total n =aNon-Japanese Axitinib titration n=6 Placebo titration n=5 Non-randomized n = 32 Totalb,c,d n = 169 -33.9 37.3 Axitinib titrationd n = 50 -33.eight 41.9 Placebo titrationc,d n = 51 -26.1 36.9 Non-randomizedd n = 59 -42.six 31.Change from baseline in sum of tumor diameter for target lesion ( ) Mean -40.2 -41.six -27.five -43.0 SD 23.two 19.five 16.three 23.aIncludes 1 patient who received therapy and withdrew for the duration of the lead-in period.