fined as an adverse reaction, regardless of causality, while on CANCIDAS or during the 14-day post-CANCIDAS follow-up period.
†
Incidence for each preferred term is ≥5% among individuals who received at least 1 dose of CANCIDAS.
‡
Within any system organ class, individuals may experience more than 1 adverse event.
All Systems, Any Adverse Reaction 1496 (85.6)
Gastrointestinal Disorders 690 (39.5)
Abdominal Pain 109 (6.2)
Diarrhea 260 (14.9)
Nausea 154 (8.8)
Vomiting 129 (7.4)
General Disorders and Administration Site Conditions 782 (44.8)
Chills 191 (10.9)
Edema Peripheral 104 (6.0)
Pyrexia 369 (21.1)
Infections and Infestations 641 (36.7)
Pneumonia 103 (5.9)
Investigations 835 (47.8)
Alanine Aminotransferase Increased 247 (14.1)
Aspartate Aminotransferase Increased 218 (12.5)
Blood Alkaline Phosphatase Increased 211 (12.1)
Blood Bilirubin Increased 111 (6.4)
Blood Potassium Decreased 206 (11.8)
Hemoglobin Decreased 95 (5.4)
Nervous System Disorders 387 (22.2)
Headache 184 (10.5)
Respiratory, Thoracic, and Mediastinal Disorders 563 (32.2)
Cough 110 (6.3)
Skin and Subcutaneous Tissue Disorders 489 (28.0)
Erythema 95 (5.4)
Rash 151 (8.6)
Vascular Disorders 306 (17.5)
Hypotension 108 (6.2)
Clinically significant adverse reactions, regardless of causality or incidence which occurred in these trials, are listed below.
Blood and lymphatic system disorders: anemia, coagulopathy, febrile neutropenia, neutropenia, thrombocytopenia
Cardiac disorders: arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, myocardial infarction, tachycardia
Gastrointestinal disorders: abdominal distension, abdominal pain upper, constipation, dyspepsia
General disorders and administration site conditions: asthenia, fatigue, infusion site pain/pruritus/swelling, mucosal inflammation, edema
Hepatobiliary disorders: hepatic failure, hepatomegaly, hepatotoxicity, hyperbilirubinemia, jaundice
Infections and infestations: bacteremia, sepsis, urinary tract infection
Metabolic and nutrition disorders: anorexia, decreased appetite, fluid overload, hypomagnesemia, hypercalcemia, hyperglycemia, hypokalemia
Musculoskeletal, connective tissue, and bone disorders: arthralgia, back pain, pain in extremity
Nervous system disorders: convulsion, dizziness, somnolence, tremor
Psychiatric disorders: anxiety, confusional state, depression, insomnia
Renal and urinary disorders: hematuria, renal failure
Respiratory, thoracic, and mediastinal disorders: dyspnea, epistaxis, hypoxia, tachypnea
Skin and subcutaneous tissue disorders: erythema, petechiae, skin lesion, urticaria
Vascular disorders: flushing, hypertension, phlebitis
6.4 Postmarketing Experience
The following additional adverse reactions have been identified during the post
