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) |
aAccording to CTC v3.0. Adverse events are shown of CTC grade 3, 4, or 5, which occurred at least in patient per event category.