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%) |
Frequency of AEs is sorted in descending order in the total column
A patient with multiple occurrences of an AE for a preferred term or system organ class is counted only once
A patient with multiple AEs within a primary system organ class is counted only once in the total row