Table 2 CTC grade ≥ 3 adverse events (AE) in patients treated with early FCR (safety population, n = 82).
Total (CTC 3–5) n (%) | CTC grade 3 n (%) | CTC grade 4 n (%) | CTC grade 5 n (%) | Unknown grade n (%) | |
|---|---|---|---|---|---|
N patients with at least one ≥ CTC grade 3 AE | 61 (74.4) | 28 (34.1) | 29 (35.4) | 4 (4.9) | 5 (6.1) |
CTC AE categorya | |||||
Blood/bone marrow | 50 (61.0) | 23 (28.0) | 26 (31.7) | 1 (1.2) | 0 (0.0) |
Neutropenia | 37 (45.1) | 15 (18.3) | 22 (26.8) | 0 (0.0) | 0 (0.0) |
Leukopenia | 25 (30.5) | 19 (23.2) | 6 (7.3) | 0 (0.0) | 0 (0.0) |
Thrombocytopenia | 5 (6.1) | 1 (1.2) | 4 (4.9) | 0 (0.0) | 0 (0.0) |
Anemia | 4 (4.9) | 4 (4.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Cytopenia | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hemolysis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
Infection | 18 (22.0) | 16 (19.5) | 1 (1.2) | 1 (1.2) | 0 (0.0) |
Respiratory tract infection | 7 (8.5) | 7 (8.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Fever/infection of unknown origin | 3 (3.7) | 3 (3.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Herpes zoster | 3 (3.7) | 3 (3.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Catheter-related infection | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
CMV reactivation | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Bursitis | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Candida esophagitis | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hepatitis B | 1 (1.2) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Sepsis | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Splondylodiscitis | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Viral encephalititis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
Metabolic/laboratory | 5 (6.1) | 4 (4.9) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Elevated GOT, GPT, or GGT | 4 (4.9) | 3 (3.7) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Hyperglycemia | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gastrointestinal | 3 (3.7) | 2 (2.4) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Nausea/vomiting | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Obstipation | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Diarrhea | 1 (1.2) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Vascular | 4 (4.9) | 4 (4.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Thrombosis | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Thrombosis with consecutive pulmonary embolism | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Ruptured aortic aneurysm | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Neurology | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Depression | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Orthostasis | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pain | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Herniated disc/radiculopathy | 2 (2.4) | 2 (2.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Dermatology/skin | 2 (2.4) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Exanthema | 2 (2.4) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Circulatory symptoms/arrhythmia | 2 (2.4) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Circulatory symptoms/arrhythmia | 2 (2.4) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Cardiac arrhythmia | 1 (1.2) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Circulatory symptoms/arrythmia | 1 (1.2) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
Cardiac general | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Circulatory symptoms/arrythmia | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Constitutional symptoms | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Constitutional symptoms | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Musculoskeletal/soft tissue | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Bone fracture (nonpathologic) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Pulmonary/upper respiratory | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
Pulmonary fibrosis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
Renal/genitourinary | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
Renal insufficiency | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) |
