Number of adverse events possible, probable or definite to the study medication (including missing relationship) was higher in the bendamustine arm than in the chlorambucil arm. Especially blood and lymphatic system disorders, gastrointestinal disorders and pyrexia occurred more frequently under bendamustine than under chlorambucil. 8: Drug related adverse events by CTC category in at least 5% of patients in either treatment group by system organ class and preferred term safety population – System Organ Class BEN CLB Preferred Term (N=161) (N=151) (N=312) Blood & lymphatic system disorders Neutropaenia 43 (26.7%) 21 (13.9%) 64 (20.5%) Thrombocytopaenia 37 (23.0%) 27 (17.9%) 64 (20.5%) Anaemia 28 (17.4%) 15 (9.9%) 43 (13.8%) 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 24 (14.9%) 9 (6.0%) 33 (10.6%) Diarrhoea 13 (8.1%) 4 (2.6%) 17 (5.4%) General disorders & administration site conditions Pyrexia Asthenia 34 (21.1%) 3 (2.0%) 37 (11.9%) Fatigue 12 (7.5%) 7 (4.6%) 19 (6.1%) Chills 10 (6.2%) 4 (2.6%) 14 (4.5%) 8 (5.0%) 2 (1.3%) 10 (3.2%) Infections & infestations Infection 8 (5.0%) 1 (0.7%) 9 (2.9%) Metabolism & nutrition disorders Hyperuricaemia 9 (5.6%) 1 (0.7%) 9 (2.9%)
Number of adverse events possible, probable or definite to the study medication (including missing relationship) was higher in the bendamustine arm than in the chlorambucil arm. Especially blood and lymphatic system disorders, gastrointestinal disorders and pyrexia occurred more frequently under bendamustine than under chlorambucil. 8: Drug related adverse events by CTC category in at least 5% of patients in either treatment group by system organ class and preferred term – safety population System Organ Class Preferred Term BEN (N=161) CLB (N=151) (N=312) Blood & lymphatic system disorders Neutropaenia Thrombocytopaenia Anaemia Leukopaenia Lymphopaenia 43 (26.7%) 37 (23.0%) 28 (17.4%) 28 (17.4%) 10 (6.2%) 21 (13.9%) 27 (17.9%) 15 (9.9%) 5 (3.3%) 1 (0.7%) 64 (20.5%) 64 (20.5%) 43 (13.8%) 33 (10.6%) 11 (3.5%) Gastrointestinal disorders Nausea Vomiting Diarrhoea 31 (19.3%) 24 (14.9%) 13 (8.1%) 21 (13.9%) 9 (6.0%) 4 (2.6%) 52 (16.7%) 33 (10.6%) 17 (5.4%) General disorders & administration site conditions Pyrexia Asthenia Fatigue Chills 34 (21.1%) 12 (7.5%) 10 (6.2%) 8 (5.0%) 3 (2.0%) 7 (4.6%) 4 (2.6%) 2 (1.3%) 37 (11.9%) 19 (6.1%) 14 (4.5%) 10 (3.2%) Infections & infestations Infection 8 (5.0%) 1 (0.7%) 9 (2.9%) Metabolism & nutrition disorders Hyperuricaemia 9 (5.6%) 1 (0.7%) 9 (2.9%)
auspar-bendamustine-150106-pi.docx