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Transcription:

Supplementary webappendix This webappendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Elter T, Gercheva-Kyuchukova L, Pylylpenko H, et al. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol 2011; published online Oct 11, 2011. DOI:10.1016/S1470-2045(11)70242-X.

Web Extra Table 1: AEs Occurring in 5% of Rai Stage I-II Patients (N=102) (N=102) Rai stage I-II patients with at least 1 AE 101 (99 0) 7 19 39 30 6 88 (86 3) 18 22 30 14 4 Pyrexia 64 (62 7) 33 26 5 0 0 2 (1 9) 1 1 0 0 0 Neutropenia 53 (52 0) 1 10 26 16 0 48 (47 1) 2 13 20 13 0 Leukopenia 48 (47 1) 2 13 22 11 0 18 (17 6) 0 8 7 3 0 Chills 33 (32 4) 23 7 3 0 0 1 (1 0) 1 0 0 0 0 Thrombocytopenia 27 (26 5) 12 9 3 3 0 21 (20 6) 10 5 6 0 0 Lymphopenia 24 (23 5) 0 3 9 12 0 4 (3 9) 0 2 2 0 0 Anaemia 23 (22 3) 9 7 7 0 0 17 (16 7) 4 7 6 0 0 Urticaria 16 (15 7) 4 10 2 0 0 1 (1 0) 0 1 0 0 0 CMV test positive 16 (15 7) 12 4 0 0 0 1 (1 0) 1 0 0 0 0 Rash 16 (15 7) 8 8 0 0 0 4 (3 9) 3 1 0 0 0 Infusion-related reaction 15 (14 7) 4 5 6 0 0 0 (0 0) 0 0 0 0 0 Dermatitis allergic 10 (9 8) 4 6 0 0 0 3 (2 9) 2 1 0 0 0 Bronchitis 10 (9 8) 0 7 3 0 0 3 (2 9) 0 2 1 0 0 Cough 10 (9 8) 8 1 1 0 0 3 (2 9) 3 0 0 0 0 Hypertension 10 (9 8) 3 5 2 0 0 4 (3 9) 2 1 1 0 0 Nausea 9 (8 8) 8 1 0 0 0 10 (9 8) 9 1 0 0 0 Diarrhoea 8 (7 8) 4 3 1 0 0 5 (4 9) 4 1 0 0 0 Bronchospasm 8 (7 8) 0 1 7 0 0 0 (0 0) 0 0 0 0 0 Pruritus 7 (6 9) 3 4 0 0 0 2 (2 0) 2 0 0 0 0 Increased ALT 6 (5 9) 4 1 1 0 0 4 (3 9) 2 1 1 0 0 Bone pain 6 (5 9) 0 6 0 0 0 0 (0 0) 0 0 0 0 0 Headache 6 (5 9) 3 3 0 0 0 4 (3 9) 4 0 0 0 0 Pharyngitis 6 (5 9) 1 4 1 0 0 2 (2 0) 2 0 0 0 0 Vomiting 6 (5 9) 5 0 1 0 0 2 (2 0) 1 1 0 0 0 Fatigue 4 (3 9) 3 0 0 1 0 6 (5 9) 5 0 1 0 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus; ALT, Alanine transaminase Page 1 of 6 Web Extra Material

Web Extra Table 2: AEs Occurring in 5% of Rai Stage III-IV Patients (N=60) (N=61) Any grade Maximum Grade Any grade Maximum Grade Rai stage III-IV patients with at least 1 AE 58 (96 7) 3 11 21 19 4 59 (96 7) 2 4 23 22 8 Pyrexia 33 (55 0) 16 15 1 1 0 12 (19 7) 4 6 2 0 0 Neutropenia 32 (53 3) 2 0 19 11 0 34 (55 7) 0 4 13 17 0 Leukopenia 25 (41 7) 2 5 11 7 0 7 (11 5) 0 2 5 0 0 Thrombocytopenia 20 (33 3) 5 5 5 5 0 24 (39 3) 3 8 9 4 0 Chills 16 (26 7) 8 8 0 0 0 1 (1 6) 1 0 0 0 0 Anaemia 12 (20 0) 4 4 3 1 0 23 (37 7) 2 6 9 6 0 Nausea 11 (18 3) 8 2 1 0 0 3 (4 9) 3 0 0 0 0 Lymphopenia 11 (18 3) 0 1 3 7 0 3 (4 9) 0 2 0 1 0 Rash 9 (15 0) 4 4 1 0 0 1 (1 6) 1 0 0 0 0 Vomiting 9 (15 0) 6 2 1 0 0 1 (1 6) 0 1 0 0 0 Headache 8 (13 3) 5 3 0 0 0 0 (0 0) 0 0 0 0 0 Diarrhoea 8 (13 3) 4 2 2 0 0 6 (9 8) 2 4 0 0 0 Infusion-related reaction 8 (13 3) 2 4 2 0 0 0 (0 0) 0 0 0 0 0 Fatigue 7 (11 7) 6 0 1 0 0 3 (4 9) 1 2 0 0 0 Pruritus 7 (11 7) 4 2 1 0 0 2 (3 3) 1 1 0 0 0 Urticaria 7 (11 7) 1 5 1 0 0 3 (4 9) 1 1 1 0 0 Bronchitis 6 (10 0) 2 3 1 0 0 2 (3 3) 1 1 0 0 0 Decreased WBC count 6 (10 0) 1 1 2 2 0 2 (3 3) 1 1 0 0 0 Cytokine release syndrome 5 (8 3) 1 2 2 0 0 0 (0 0) 0 0 0 0 0 Constipation 5 (8 3) 4 1 0 0 0 0 (0 0) 0 0 0 0 0 Insomnia 5 (8 3) 3 2 0 0 0 0 (0 0) 0 0 0 0 0 Pneumonia 5 (8 3) 3 1 1 0 0 3 (4 9) 1 1 1 0 0 Dermatitis allergic 4 (6 7) 2 1 1 0 0 0 (0 0) 0 0 0 0 0 Dyspnoea 4 (6 7) 2 1 1 0 0 0 (0 0) 0 0 0 0 0 Decreased neutrophil count 4 (6 7) 0 0 3 1 0 6 (9 8) 1 1 3 1 0 Decreased platelet count 4 (6 7) 3 1 0 0 0 8 (13 1) 2 3 2 1 0 Bone pain 3 (5 0) 2 1 0 0 0 0 (0 0) 0 0 0 0 0 Cough 3 (5 0) 1 2 0 0 0 5 (8 2) 3 2 0 0 0 CMV test positive 3 (5 0) 2 0 1 0 0 0 (0 0) 0 0 0 0 0 Dizziness 3 (5 0) 3 0 0 0 0 2 (3 3) 1 1 0 0 0 Decreased haemoglobin 3 (5 0) 1 2 0 0 0 5 (8 2) 2 1 1 1 0 Hiccups 3 (5 0) 3 0 0 0 0 0 (0 0) 0 0 0 0 0 Respiratory tract infection 3 (5 0) 3 0 0 0 0 3 (4 9) 1 1 0 1 0 Pollakiuria 3 (5 0) 1 1 1 0 0 0 (0 0) 0 0 0 0 0 Febrile Neutropenia 1 (1 7) 0 0 1 0 0 6 (9 8) 0 0 5 1 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus; WBC, White blood cell Page 2 of 6 Web Extra Material

Web Extra Table 3: AEs Occurring in 5% of Patients 65 years of Age (N=55) (N=59) Patients 65 years old with at least 1 AE 54 (98 2) 4 9 21 15 5 56 (94 9) 7 9 20 14 6 Pyrexia 30 (54 5) 13 14 2 1 0 3 (5 1) 0 3 0 0 0 Neutropenia 28 (50 9) 1 4 16 7 0 32 (54 2) 1 5 13 13 0 Leukopenia 22 (40 0) 0 7 9 6 0 13 (22 0) 0 4 7 2 0 Chills 20 (36 4) 11 9 0 0 0 2 (3 4) 2 0 0 0 0 Thrombocytopenia 17 (30 9) 7 3 2 5 0 18 (30 5) 5 6 6 1 0 Lymphopenia 13 (23 6) 0 1 5 7 0 3 (5 1) 0 3 0 0 0 Anaemia 12 (21 8) 5 2 4 1 0 18 (30 5) 4 10 4 0 0 Diarrhoea 8 (14 5) 4 3 1 0 0 4 (6 8) 1 3 0 0 0 Rash 8 (14 5) 5 3 0 0 0 1 (1 7) 1 0 0 0 0 Cough 7 (12 7) 5 2 0 0 0 4 (6 8) 2 2 0 0 0 Hypertension 7 (12 7) 4 2 1 0 0 5 (8 5) 2 1 2 0 0 Nausea 7 (12 7) 5 2 0 0 0 3 (5 1) 3 0 0 0 0 CMV test positive 6 (10 9) 4 1 1 0 0 1 (1 7) 1 0 0 0 0 Pruritus 6 (10 9) 3 3 0 0 0 1 (1 7) 1 0 0 0 0 Vomiting 6 (10 9) 5 1 0 0 0 0 (0 0) 0 0 0 0 0 Infusion-related reaction 5 (9 1) 2 2 1 0 0 0 (0 0) 0 0 0 0 0 Pneumonia 5 (9 1) 2 0 3 0 0 2 (3 4) 0 1 1 0 0 Urticaria 5 (9 1) 2 3 0 0 0 2 (3 4) 1 1 0 0 0 Increased blood creatinine 4 (7 3) 1 2 1 0 0 1 (1 7) 0 1 0 0 0 Bone pain 4 (7 3) 1 3 0 0 0 0 (0 0) 0 0 0 0 0 Decreased WBC count 4 (7 3) 0 1 2 1 0 2 (3 4) 1 1 0 0 0 Back pain 3 (5 5) 2 1 0 0 0 1 (1 7) 0 0 1 0 0 Bronchitis 3 (5 5) 1 2 0 0 0 1 (1 7) 0 1 0 0 0 Constipation 3 (5 5) 2 1 0 0 0 2 (3 4) 0 1 1 0 0 Dizziness 3 (5 5) 3 0 0 0 0 2 (3 4) 1 1 0 0 0 Dyspnoea 3 (5 5) 1 1 1 0 0 0 (0 0) 0 0 0 0 0 Fatigue 3 (5 5) 3 0 0 0 0 4 (6 8) 2 2 0 0 0 Febrile neutropenia 3 (5 5) 0 0 3 0 0 4 (6 8) 0 0 3 1 0 Headache 3 (5 5) 2 1 0 0 0 0 (0 0) 0 0 0 0 0 Nasopharyngitis 3 (5 5) 1 2 0 0 0 5 (8 5) 3 2 0 0 0 Decreased neutrophil count 3 (5 5) 0 0 2 1 0 4 (6 8) 0 2 1 1 0 Decreased platelet count 3 (5 5) 3 0 0 0 0 6 (10 2) 1 2 2 1 0 Pleural effusion 3 (5 5) 2 1 0 0 0 0 (0 0) 0 0 0 0 0 Urinary tract infection 3 (5 5) 0 3 0 0 0 0 (0 0) 0 0 0 0 0 Increased ALT 2 (3 6) 2 0 0 0 0 3 (5 1) 1 1 1 0 0 Asthenia 2 (3 6) 1 1 0 0 0 5 (8 5) 3 1 1 0 0 Decreased haemoglobin 2 (3 6) 1 1 0 0 0 3 (5 1) 1 1 1 0 0 Abdominal pain upper 0 (0 0) 0 0 0 0 3 (5 1) 0 3 0 0 0 Upper respiratory tract infection 0 (0 0) 0 0 0 0 3 (5 1) 0 0 3 0 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus; WBC, White blood cell count; ALT, Alanine transaminase Page 3 of 6 Web Extra Material

Web Extra Table 4: AEs Occurring in 5% of Patients < 65 years of Age (N=109) (N=106) Patients 65 years old with at least 1 AE 107 (98 2) 6 22 39 35 5 93 (87 7) 13 17 35 22 6 Pyrexia 68 (62 4) 37 27 4 0 0 12 (11 3) 5 5 2 0 0 Neutropenia 58 (53 2) 2 6 29 21 0 52 (49 1) 1 13 21 17 0 Leukopenia 52 (47 7) 4 11 24 13 0 13 (12 3) 0 6 6 1 0 Thrombocytopenia 30 (27 5) 10 11 6 3 0 27 (25 5) 8 7 9 3 0 Chills 29 (26 6) 20 6 3 0 0 0 (0 0) 0 0 0 0 0 Anaemia 24 (22 0) 8 10 6 0 0 23 (21 7) 3 3 11 6 0 Lymphopenia 22 (20 2) 0 3 7 12 0 4 (3 8) 0 1 2 1 0 Infusion-related reaction 18 (16 5) 4 7 7 0 0 0 (0 0) 0 0 0 0 0 Urticaria 18 (16 5) 3 12 3 0 0 2 (1 9) 0 1 1 0 0 Rash 17 (15 6) 7 9 1 0 0 4 (3 8) 3 1 0 0 0 CMV test positive 14 (12 8) 11 3 0 0 0 0 (0 0) 0 0 0 0 0 Bronchitis 13 (11 9) 1 8 4 0 0 4 (3 8) 1 2 1 0 0 Nausea 13 (11 9) 11 1 1 0 0 10 (9 4) 9 1 0 0 0 Dermatitis allergic 12 (11 0) 5 6 1 0 0 4 (3 8) 2 2 0 0 0 Headache 11 (10 1) 6 5 0 0 0 4 (3 8) 4 0 0 0 0 Vomiting 9 (8 3) 6 1 2 0 0 3 (2 8) 1 2 0 0 0 Diarrhoea 8 (7 3) 4 2 2 0 0 7 (6 6) 5 2 0 0 0 Fatigue 8 (7 3) 6 0 1 1 0 5 (4 7) 4 0 1 0 0 Pruritus 8 (7 3) 4 3 1 0 0 3 (2 8) 2 1 0 0 0 Bronchospasm 7 (6 4) 0 1 6 0 0 0 (0 0) 0 0 0 0 0 Cough 6 (5 5) 4 1 1 0 0 4 (3 8) 4 0 0 0 0 Cytokine release syndrome 6 (5 5) 1 3 2 0 0 0 (0 0) 0 0 0 0 0 Hyperthermia 6 (5 5) 2 4 0 0 0 0 (0 0) 0 0 0 0 0 Pharyngitis 6 (5 5) 1 4 1 0 0 5 (4 7) 5 0 0 0 0 Pneumonia 6 (5 5) 1 2 1 1 1 1 (0 9) 1 0 0 0 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus Page 4 of 6 Web Extra Material

Web Extra Table 5: AEs Occurring in 5% of Male Patients (N=105) (N=106) Male patients with at least 1 AE 103 (98 1) 8 22 37 30 6 95 (89 6) 14 17 36 18 10 Pyrexia 61 (58 1) 30 25 5 1 0 9 (8 5) 3 5 1 0 0 Neutropenia 51 (48 6) 2 4 25 20 0 49 (46 2) 1 10 23 15 0 Leukopenia 40 (38 1) 2 8 20 10 0 15 (14 2) 0 6 7 2 0 Thrombocytopenia 32 (30 5) 10 11 5 6 0 29 (27 4) 11 12 6 0 0 Chills 30 (28 6) 18 10 2 0 0 2 (1 9) 2 0 0 0 0 Anaemia 15 (14 3) 8 4 2 1 0 24 (22 6) 6 8 8 2 0 Lymphopenia 14 (13 3) 0 2 5 7 0 3 (2 8) 0 0 2 1 0 Rash 12 (11 4) 5 7 0 0 0 3 (2 8) 2 1 0 0 0 Urticaria 12 (11 4) 5 7 0 0 0 2 (1 9) 1 1 0 0 0 Bronchitis 11 (10 5) 2 7 2 0 0 2 (1 9) 0 1 1 0 0 Infusion-related reaction 11 (10 5) 4 6 1 0 0 0 (0 0) 0 0 0 0 0 Nausea 10 (9 5) 8 1 1 0 0 8 (7 5) 7 1 0 0 0 CMV DNA test positive 9 (8 6) 8 0 1 0 0 1 (0 9) 1 0 0 0 0 Diarrhoea 9 (8 6) 4 3 2 0 0 4 (3 8) 3 1 0 0 0 Fatigue 9 (8 6) 7 0 1 1 0 6 (5 7) 5 1 0 0 0 Vomiting 8 (7 6) 5 1 2 0 0 2 (1 9) 0 2 0 0 0 Cough 7 (6 7) 4 2 1 0 0 5 (4 7) 4 1 0 0 0 Headache 7 (6 7) 2 5 0 0 0 2 (1 9) 2 0 0 0 0 Dermatitis allergic 6 (5 7) 4 1 1 0 0 1 (0 9) 0 1 0 0 0 Hypertension 6 (5 7) 3 3 0 0 0 5 (4 7) 3 0 2 0 0 Pneumonia 6 (5 7) 2 1 2 1 0 2 (1 9) 1 0 1 0 0 Decreased platelet count 3 (2 9) 2 1 0 0 0 6 (5 7) 3 2 1 0 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus Page 5 of 6 Web Extra Material

Web Extra Table 6: AEs Occurring in 5% of Female Patients (N=59) (N=59) Female patients with at least 1 AE 58 (98 3) 2 9 23 20 4 54 (91 5) 6 9 19 18 2 Pyrexia 37 (62 7) 20 16 1 0 0 6 (10 2) 2 3 1 0 0 Neutropenia 35 (59 3) 1 6 20 8 0 35 (59 3) 1 8 11 15 0 Leukopenia 34 (57 6) 2 10 13 9 0 11 (18 6) 0 4 6 1 0 Anaemia 21 (35 6) 5 8 8 0 0 17 (28 8) 1 5 7 4 0 Lymphopenia 21 (35 6) 0 2 7 12 0 4 (6 8) 0 4 0 0 0 Chills 19 (32 2) 13 5 1 0 0 0 (0 0) 0 0 0 0 0 Thrombocytopenia 15 (25 4) 7 3 3 2 0 16 (27 1) 2 1 8 5 0 Rash 13 (22 0) 7 5 1 0 0 2 (3 4) 2 0 0 0 0 Infusion-related reaction 12 (20 3) 2 3 7 0 0 0 (0 0) 0 0 0 0 0 Urticaria 11 (18 6) 0 8 3 0 0 2 (3 4) 0 1 1 0 0 CMV test positive 11 (18 6) 7 4 0 0 0 0 (0 0) 0 0 0 0 0 Nausea 10 (16 9) 8 2 0 0 0 5 (8 5) 5 0 0 0 0 Pruritus 9 (15 3) 5 3 1 0 0 2 (3 4) 1 1 0 0 0 Dermatitis allergic 8 (13 6) 2 6 0 0 0 3 (5 1) 2 1 0 0 0 Bronchospasm 7 (11 9) 0 1 6 0 0 0 (0 0) 0 0 0 0 0 Diarrhoea 7 (11 9) 4 2 1 0 0 7 (11 9) 3 4 0 0 0 Headache 7 (11 9) 6 1 0 0 0 2 (3 4) 2 0 0 0 0 Vomiting 7 (11 9) 6 1 0 0 0 1 (1 7) 1 0 0 0 0 Bone pain 6 (10 2) 1 5 0 0 0 0 (0 0) 0 0 0 0 0 Cough 6 (10 2) 5 1 0 0 0 3 (5 1) 2 1 0 0 0 Hypertension 6 (10 2) 2 2 2 0 0 1 (1 7) 0 1 0 0 0 Bronchitis 5 (8 5) 0 3 2 0 0 3 (5 1) 1 2 0 0 0 Pneumonia 5 (8 5) 1 1 2 0 1 1 (1 7) 0 1 0 0 0 Cholecystitis chronic 4 (6 8) 1 3 0 0 0 1 (1 7) 0 1 0 0 0 Drug eruption 4 (6 8) 0 1 3 0 0 0 (0 0) 0 0 0 0 0 Stomatitis 4 (6 8) 1 3 0 0 0 0 (0 0) 0 0 0 0 0 Asthenia 3 (5 1) 2 1 0 0 0 2 (3 4) 0 1 1 0 0 CMV infection 3 (5 1) 0 1 2 0 0 0 (0 0) 0 0 0 0 0 Decreased haemoglobin 3 (5 1) 2 1 0 0 0 3 (5 1) 1 1 1 0 0 Decreased platelet count 3 (5 1) 2 1 0 0 0 4 (6 8) 0 2 1 1 0 Pollakiuria 3 (5 1) 3 0 0 0 0 0 (0 0) 0 0 0 0 0 Pruritus allergic 3 (5 1) 1 1 1 0 0 0 (0 0) 0 0 0 0 0 Respiratory tract infection viral 3 (5 1) 0 3 0 0 0 1 (1 7) 0 1 0 0 0 Decreased WBC count 3 (5 1) 0 0 3 0 0 2 (3 4) 0 2 0 0 0 Fatigue 2 (3 4) 2 0 0 0 0 3 (5 1) 1 1 1 0 0 Nasopharyngitis 2 (3 4) 2 0 0 0 0 4 (6 8) 3 1 0 0 0 Decreased neutrophil count 2 (3 4) 0 0 2 0 0 3 (5 1) 0 1 1 1 0 Febrile neutropenia 2 (3 4) 0 0 2 0 0 4 (6 8) 0 0 2 2 0 Respiratory tract infection 1 (1 7) 0 1 0 0 0 3 (5 1) 1 2 0 0 0 Herpes zoster 0 (0 0) 0 0 0 0 0 3 (5 1) 2 1 0 0 0 Peripheral sensory neuropathy 0 (0 0) 0 0 0 0 0 3 (5 1) 1 1 1 0 0 AE, adverse event (regardless of causality, unless otherwise specified); CMV, Cytomegalovirus; WBC, White blood cell Page 6 of 6 Web Extra Material

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