The following tables describe the safety results reported in study 02CLLIII of 161 previously-untreated patients with Binet Stage B or C CLL requiring treatment. Table 6: Adverse events occurring in at least 5% of patients in either treatment group by system organ class and preferred term safety population – System Class BEN CLB Total Preferred Term (N = 161) (N=151) (N=312) Blood & lymphatic system disorders Neutropaenia 44 (27.3%) 21 (13.9%) 65 (20.8%) Thrombocytopaenia 40 (24.8%) 31 (20.5%) 71 (22.8%) Anaemia 35 (21.7%) 21 (13.9%) 56 (17.9%) Leukopaenia 28 (17.4%) 5 (3.3%) 33 (10.6%) Lymphopaenia 10 (6.2%) 1 (0.7%) 11 (3.5%) Gastrointestinal disorders Nausea 31 (19.3%) 21 (13.9%) 52 (16.7%) Vomiting 25 (15.5%) 10 (6.6%) 35 (11.2%) Diarrhoea 16 (9.9%) 6 (4.0%) 22 (7.1%) General disorders & administration site 40 (24.8%) conditions 14 (8.7%) Pyrexia 14 (8.7%) 8 (5.3%) 48 (15.4%) Asthenia 9 (5.6%) 7 (4.6%) 21 (6.7%) Fatigue 7 (4.6%) 21 (6.7%) Chills 2 (1.3%) 11 (3.5%) Immune system disorders 8 (5.0%) 3 (2.0%) 11 (3.5%) Hypersensitivity Infections & infestations Nasopharyngitis 11 (6.8%) 11 (7.3%) 22 (7.1%) Infection 10 (6.2%) 2 (1.3%) 12 (3.8%)
The following tables describe the safety results reported in study 02CLLIII of 161 previously-untreated patients with Binet Stage B or C CLL requiring treatment. Table 6: Adverse events occurring in at least 5% of patients in either treatment group by system organ class and preferred term – safety population System Class Preferred Term BEN (N = 161) CLB (N=151) Total (N=312) Blood & lymphatic system disorders Neutropaenia Thrombocytopaenia Anaemia Leukopaenia Lymphopaenia 44 (27.3%) 40 (24.8%) 35 (21.7%) 28 (17.4%) 10 (6.2%) 21 (13.9%) 31 (20.5%) 21 (13.9%) 5 (3.3%) 1 (0.7%) 65 (20.8%) 71 (22.8%) 56 (17.9%) 33 (10.6%) 11 (3.5%) Gastrointestinal disorders Nausea Vomiting Diarrhoea 31 (19.3%) 25 (15.5%) 16 (9.9%) 21 (13.9%) 10 (6.6%) 6 (4.0%) 52 (16.7%) 35 (11.2%) 22 (7.1%) General disorders & administration site conditions Pyrexia Asthenia Fatigue Chills 40 (24.8%) 14 (8.7%) 14 (8.7%) 9 (5.6%) 8 (5.3%) 7 (4.6%) 7 (4.6%) 2 (1.3%) 48 (15.4%) 21 (6.7%) 21 (6.7%) 11 (3.5%) Immune system disorders Hypersensitivity 8 (5.0%) 3 (2.0%) 11 (3.5%) Infections & infestations Nasopharyngitis Infection 11 (6.8%) 10 (6.2%) 11 (7.3%) 2 (1.3%) 22 (7.1%) 12 (3.8%)
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