Table 5 Treatment Emergent Adverse Events occurring in >/= 1% of Zonisamide treated patients and greater than placebo Body System and COSTART Number (%) of Subjects Preferred Term All Doses Placebo (N=498) (N=350) Any adverse event 388 (77.9) 237 (67.7) Body as a whole 36 (7.2) 12 (3.4) Abdominal pain 5 (1.0) 2 (0.6) Allergic Reaction 20 (4.0) 10 (2.9) Flu syndrome 18 (3.6) 11 (3.1) Pain 7 (1.4) 4 (1.1) Viral Infection Cardiovascular 7 (1.4) 2 (0.6) Vasodilatation Digestive 54 (10.8) 15 (4.3) Anorexia 14 (2.8) 4 (1.1) Constipation 29 (5.8) 13 (3.7) Diarrhoea 5 (1.0) 2 (0.6) Dry mouth 13 (2.6) 3 (0.9) Dyspepsia 48 (9.6) 28 (8.0) Nausea Hematologic and Lymphatic 11 (2.2) 3 (0.9) Ecchymosis 7 (1.4) 0 (0.0) Leukopenia Metabolic and Nutritional 20 (4.0) 6 (1.7) Weight loss Musculoskeletal 5 (1.0) 3 (0.9) Arthralgia 5 (1.0) 1 (0.3) Myasthenia Nervous system 13 (2.6) 5 (1.4) Abnormal gait 37 (7.4) 17 (4.9) Agitation/irritability 78 (15.7) 23 (6.6) Altered cognitive function 19 (3.8) 11 (3.1) Anxiety 28 (5.6) 8 (2.3) Ataxia 141 (28.3) 65 (18.6) CNS depression 28 (5.6) 9 (2.6) Confusion 31 (6.2) 10 (2.9) Depression
Table 5 Treatment Emergent Adverse Events occurring in >/= 1% of Zonisamide treated patients and greater than placebo Body System and COSTART Preferred Term Number (%) of Subjects All Doses Placebo (N=498) (N=350) Any adverse event 388 (77.9) 237 (67.7) Body as a whole Abdominal pain 36 (7.2) 12 (3.4) Allergic Reaction 5 (1.0) 2 (0.6) Flu syndrome 20 (4.0) 10 (2.9) Pain 18 (3.6) 11 (3.1) Viral Infection 7 (1.4) 4 (1.1) Cardiovascular Vasodilatation 7 (1.4) 2 (0.6) Digestive Anorexia 54 (10.8) 15 (4.3) Constipation 14 (2.8) 4 (1.1) Diarrhoea 29 (5.8) 13 (3.7) Dry mouth 5 (1.0) 2 (0.6) Dyspepsia 13 (2.6) 3 (0.9) Nausea 48 (9.6) 28 (8.0) Hematologic and Lymphatic Ecchymosis 11 (2.2) 3 (0.9) Leukopenia 7 (1.4) 0 (0.0) Metabolic and Nutritional Weight loss 20 (4.0) 6 (1.7) Musculoskeletal Arthralgia 5 (1.0) 3 (0.9) Myasthenia 5 (1.0) 1 (0.3) Nervous system Abnormal gait 13 (2.6) 5 (1.4) Agitation/irritability 37 (7.4) 17 (4.9) Altered cognitive function 78 (15.7) 23 (6.6) Anxiety 19 (3.8) 11 (3.1) Ataxia 28 (5.6) 8 (2.3) CNS depression 141 (28.3) 65 (18.6) Confusion 28 (5.6) 9 (2.6) Depression 31 (6.2) 10 (2.9)
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