.9)
Rash 53 (35.8)
Dry Skin 21 (14.2)
Contusion 12 (8.1)
Night Sweats 12 (8.1)
Sweating Increased 10 (6.8)
Ecchymosis 8 (5.4)
Erythema 8 (5.4)
Gastrointestinal Disorders
Diarrhea 72 (48.6)
Constipation 35 (23.6)
Nausea 35 (23.6)
Abdominal Pain 18 (12.2)
Vomiting 15 (10.1)
Abdominal Pain Upper 12 (8.1)
Dry Mouth 10 (6.8)
Loose Stools 9 (6.1)
Respiratory, Thoracic and Mediastinal Disorders
Nasopharyngitis 34 (23.0)
Cough 29 (19.6)
Dyspnea 25 (16.9)
Pharyngitis 23 (15.5)
Epistaxis 22 (14.9)
Dyspnea Exertional 10 (6.8)
Rhinitis 10 (6.8)
Bronchitis 9 (6.1)
General Disorders and Administration Site Conditions
Fatigue 46 (31.1)
Pyrexia 31 (20.9)
Edema Peripheral 30 (20.3)
Asthenia 22 (14.9)
Edema 15 (10.1)
Pain 10 (6.8)
Rigors 9 (6.1)
Chest Pain 8 (5.4)
Musculoskeletal and Connective Tissue Disorders
Arthralgia 32 (21.6)
Back Pain 31 (20.9)
Muscle Cramp 27 (18.2)
Pain in Limb 16 (10.8)
Myalgia 13 (8.8)
Peripheral Swelling 12 (8.1)
Nervous System Disorders
Dizziness 29 (19.6)
Headache 29 (19.6)
Hypoesthesia 10 (6.8)
Dysgeusia 9 (6.1)
Peripheral Neuropathy 8 (5.4)
Infections and Infestations
Upper Respiratory Tract Infection 22 (14.9)
Pneumonia 17 (11.5)
Urinary Tract Infection 16 (10.8)
Sinusitis 12 (8.1)
Cellulitis 8 (5.4)
Metabolism and Nutrition Disorders
Hypokalemia 16 (10.8)
Anorexia 15 (10.1)
Hypomagnesemia 9 (6.1)
Investigations
Alanine Aminotransferase Increased 12 (8.1)
Psychiatric Disorders
Insomnia 15 (10.1)
Depression 8 (5.4)
Renal and Urinary Disorders
Dysuria 10 (6.8)
Vascular Disorders
Hypertension 9 ( 6.1)
Endocrine Disorders
Acquired Hypothyroidism 10 (6.8)
Cardiac Disorders
Palpitations 8 (5.4)
Table 7: Most Frequently Observed Grade 3 and 4 Adverse Events [1] Regardless of Relationship to Study Drug Treatment [1] Adverse events with frequency ≥1% in the 10 mg Overall group. Grade 3 and 4 are based on National Cancer Institute Common Toxicity Criteria version 2.
[2] Preferred Terms are coded using the MedDRA dictionary. A patient with multiple occurrences of an AE is counted only once in the Preferred Term category.
Preferred term [2] 10 mg
(N=148)
Patients with at least one Grade 3/4 AE 131 (88.5)
Neutropenia 79 (53.4)
Thrombocytopenia 74 (50.0)
Pneumonia 11 (7.4)
Rash 10 (6.8)
Anemia 9 (6.1)
Leukopenia 8 (5.4)
Fatigue 7 (4.7)
Dyspnea 7 (4.7)
Back Pain 7 (4.7)
Febrile Neutropenia 6 (4.1)
Nausea 6 (4.1)
Diarrhea 5 (3.4)
Pyrexia 5 (3.4)
Sepsis 4 (2.7)
Dizziness 4 (2.7)
Granulocytopenia 3 (2.0)
Chest Pain 3 (2.0)
Pulmonary Embolism 3 (2.0)
Respiratory Distress 3 (2.0)
Pruritus 3 (2.0)
Pancytopenia 3 (2.0)
Muscle Cramp 3 (2.0)
Respir |
