V9.2 SAS System Output

Table 3 Summary of On-therapy Adverse Events

Programming notes:The percentages, mean, and the standard deviations should be calculated using little 'n'.System Organ ClassPreferred TermPlacebo(N=3)Active(N=3)Patients Any Ae3(100)3(100)CARDIAC DISORDERS2(66.7)1(33.3)Atrial Fibrillation0(0)1(33.3)Palpitations1(33.3)0(0)Supraventricular Extrasystoles1(33.3)0(0)GASTROINTESTINAL DISORDERS3(100)0(0)Colitis Ulcerative1(33.3)0(0)Diarrhoea1(33.3)0(0)Flatulence1(33.3)0(0)GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS3(100)0(0)Chest Pain1(33.3)0(0)Oedema Peripheral2(66.7)0(0)INFECTIONS AND INFESTATIONS1(33.3)0(0)Viral Infection1(33.3)0(0)INJURY, POISONING AND PROCEDURAL COMPLICATIONS1(33.3)1(33.3)Chemical Burn Of Skin1(33.3)0(0)Thermal Burn0(0)1(33.3)INVESTIGATIONS1(33.3)3(100)Blood Pressure Increased1(33.3)1(33.3)Electrocardiogram Low Voltage0(0)1(33.3)Qrs Axis Abnormal0(0)1(33.3)MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS3(100)2(66.7)Arthralgia2(66.7)1(33.3)Muscle Strain1(33.3)0(0)Psoriatic Arthropathy0(0)1(33.3)NERVOUS SYSTEM DISORDERS1(33.3)0(0)Insomnia1(33.3)0(0)RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS4(133.3)2(66.7)Cough1(33.3)0(0)Dyspnoea1(33.3)0(0)Nasopharyngitis1(33.3)1(33.3)Rhonchi0(0)1(33.3)Upper Respiratory Tract Infection1(33.3)0(0)SKIN AND SUBCUTANEOUS TISSUE DISORDERS0(0)2(66.7)Pruritus0(0)1(33.3)Psoriasis0(0)1(33.3)VASCULAR DISORDERS1(33.3)1(33.3)Hypertension1(33.3)1(33.3)