Safety Information
  • Information on adverse drug reactions

Information on adverse drug reactions (pre-approval)

Adverse drug reactions

In total of all Japanese clinical studies, adverse drug reactions were observed in 36 (12.9%) of the 279 patients for safety evaluation. Major adverse drug reactions included elevated serum AST (GOT) in 10 patients (3.6%), elevated serum ALT (GPT) in 8 patients (2.9%), catheter site hemorrhage in 7 patients (2.5%), and red blood cells in urinary sediment in 5 patients (1.8%).
A clinically significant adverse drug reaction of pulmonary hemorrhage was observed in 1 patient (0.4%).

List of adverse drug reactions (pre-approval)

  pre-approval
Number of patients in analysis (1) 279
Number of patients developing adverse drug reactions (2) 36
Number of episodes of adverse drug reactions 98
Incidences of adverse drug reactions ((2)/(1) x 100) 12.9%
Adverse drug reactions Patients developing adverse drug reactions (%)
Blood and lymphatic system disorders 1(0.4)
Anemia 1(0.4)
Respiratory, thoracic, and mediastinal disorders 3(1.1)
Pulmonary hemorrhage 1(0.4)
Epistaxis 1(0.4)
Dyspnea 2(0.7)
Gastrointestinal disorders 5(1.8)
Mouth hemorrhage 4(1.4)
Gastric ulcer 1(0.4)
Hepatobiliary disorders 2(0.7)
Jaundice 2(0.7)
Skin and subcutaneous tissue disorders 8(2.9)
Purpura 3(1.1)
Petechiae 1(0.4)
Erythema multiforme 1(0.4)
Rash pruritic 1(0.4)
Rash papular 1(0.4)
Henoch-Schonlein purpura 1(0.4)
Renal and urinary disorders 3(1.1)
Hematuria 3(1.1)
General disorders and administration site conditions 11(3.9)
Catheter site hemorrhage 7(2.5)
Vascular puncture site hemorrhage 2(0.7)
Pyrexia 2(0.7)
Chest discomfort 1(0.4)
Edema 1(0.4)
Laboratory test 23(8.2)
Fecal occult blood positive 1(0.4)
Blood urine present 4(1.4)
Red blood cells urine positive 5(1.8)
White blood cells urine positive 1(0.4)
Urinary casts 1(0.4)
Protein urine present 3(1.1)
Glucose urine present 1(0.4)
Red blood cell count decreased 2(0.7)
Hemoglobin decreased 2(0.7)
Hematocrit decreased 2(0.7)
Aspartate aminotransferase (AST) increased 10(3.6)
Alanine aminotransferase (ALT) increased 8(2.9)
Blood bilirubin increased 2(0.7)
Blood cholinesterase decreased 2(0.7)
Blood alkaline phosphatase increased 4(1.4)
Blood lactate dehydrogenase (LDH) increased 1(0.4)
Blood triglycerides increased 2(0.7)
Blood cholesterol increased 1(0.4)
Blood cholesterol decreased 1(0.4)
Blood uric acid decreased 2(0.7)
Blood glucose decreased 1(0.4)
Blood potassium increased 1(0.4)
Blood potassium decreased 1(0.4)
Blood sodium increased 1(0.4)
Blood chloride increased 1(0.4)
Blood chloride decreased 1(0.4)
Injury, poisoning and procedural complications 1(0.4)
Subcutaneous hematoma 1(0.4)

Terminology: MedDRA (Version 8.1); abbreviations are used for some terms.

For adverse drug reactions observed in a Phase III clinical study, please refer to this page.