Table 4 Adverse events experienced during trastuzumab treatment in patients with HER2-positive breast cancer
System organ class | n (%) |
|---|---|
MedDRA preferred term | |
Any system organ class | |
Total | 83 (23.9%) |
Investigations | 24 (6.9%) |
Ejection fraction decreased | 25 (7.2%) |
Hepatic enzymes increased | 1 (0.3%) |
Blood and lymphatic system disorders | 15 (4.3%) |
Neutropenia | 9 (2.6%) |
Febrile neutropenia | 8 (2.3%) |
Lymphedema | 1 (0.3%) |
Gastrointestinal disorders | 15 (4.3%) |
Stomatitis | 13 (3.7%) |
Vomiting | 10 (2.9%) |
Abdominal pain upper | 2 (0.6%) |
Abdominal pain | 1 (0.3%) |
Dysphagia | 1 (0.3%) |
Gastritis | 1 (0.3%) |
Loose tooth | 1 (0.3%) |
General disorders and administration site conditions | 14 (4.0%) |
Pyrexia | 9 (2.6%) |
Pain | 5 (1.4%) |
Fatigue | 1 (0.3%) |
Cardiac disorders | 16 (4.6%) |
Cardiomyopathy | 8 (2.3%) |
Dyspnea | 6 (1.7%) |
Cardiac failure congestive | 2 (0.6%) |
Bradycardia | 1 (0.3%) |
Congestive cardiomyopathy | 1 (0.3%) |
Palpitations | 1 (0.3%) |
Nervous system disorders | 9 (2.6%) |
Neuropathy peripheral | 6 (1.7%) |
Dizziness | 2 (0.6%) |
Hypoesthesia | 1 (0.3%) |
Muscular weakness | 1 (0.3%) |
Musculoskeletal and connective tissue disorders | 7 (2.0%) |
Pain in extremity | 5 (1.4%) |
Arthralgia | 2 (0.6%) |
Back pain | 1 (0.3%) |
Bone pain | 1 (0.3%) |
Respiratory, thoracic and mediastinal disorders | 6 (1.7%) |
Cough | 3 (0.9%) |
Pleural effusion | 1 (0.3%) |
Pneumonitis | 1 (0.3%) |
Pulmonary embolism | 1 (0.3%) |
Infections and infestations | 4 (1.1%) |
Abscess limb | 1 (0.3%) |
Bronchitis | 1 (0.3%) |
Cellulitis | 1 (0.3%) |
Respiratory tract infection | 1 (0.3%) |
Injury, poisoning and procedural complications | 4 (1.1%) |
Cardiotoxicity | 4 (1.1%) |
Skin and subcutaneous tissue disorders | 4 (1.1%) |
Alopecia | 1 (0.3%) |
Dry skin | 1 (0.3%) |
Pigmentation disorder | 1 (0.3%) |
Pruritus | 1 (0.3%) |
Skin lesion | 1 (0.3%) |
Immune system disorders | 3 (0.9%) |
Hypersensitivity | 2 (0.6%) |
Skin reaction | 1 (0.3%) |
Renal and urinary disorders | 3 (0.9%) |
Flank pain | 2 (0.6%) |
Dysuria | 1 (0.3%) |
Urinary tract infection | 1 (0.3%) |
Reproductive system and breast disorders | 2 (0.6%) |
Endometrial hyperplasia | 1 (0.3%) |
Hematuria | 1 (0.3%) |
Ear and labyrinth disorders | 1 (0.3%) |
Otitis externa | 1 (0.3%) |
Metabolism and nutrition disorders | 1 (0.3%) |
Decreased appetite | 1 (0.3%) |
Vascular disorders | 1 (0.3%) |
Hot flush | 1 (0.3%) |