Table 3.
Pyrotinib-related AEs of all grades and grade 3–4.
Pyrotinib dose 320 mg daily (n = 15) | Pyrotinib dose 400 mg daily (n = 153) | Total (n = 168) | ||||
---|---|---|---|---|---|---|
AE | All grade | Grade 3–4 | All grade | Grade 3–4 | All grade | Grade 3–4 |
Diarrhea | 14 (93.0%) | 3 (20.0%) | 151 (98.7%) | 31 (20.2%) | 165 (98.2%) | 33 (19.6%) |
Nausea & vomiting | 8 (53.3%) | 1 (6.7%) | 76 (49.7%) | 12 (7.8%) | 84 (50.0%) | 13 (7.7%) |
Leukopenia | 7 (46.7%) | 1 (6.7%) | 75 (49.0%) | 12 (7.8%) | 82 (48.8%) | 13 (7.7%) |
Decreased appetite | 6 (40%) | 54 (35.3%) | 4 (2.6%) | 60 (35.7%) | 4 (2.4%) | |
Hand-foot syndrome | 4 (26.7%) | 1 (6.7%) | 43 (28.1) | 10 (6.5%) | 47 (28.0%) | 11 (6.5%) |
Asthenia | 4 (26.7%) | 28 (18.3%) | 32 (19%) | |||
Oral ulceration | 2 (13.3%) | 17 (11.1%) | 3 (2%) | 19 (11.3%) | 3 (1.8%) | |
Rash | 1 (6.7%) | 13 (8.5%) | 14 (8.3%) | |||
Dizziness | 0 (0%) | 9 (5.9%) | 9 (5.4%) | |||
Muscle spasms | 1 (6.7%) | 5 (3.4%) | 6 (3.6%) | |||
Paronychia | 1 (6.7%) | 5 (3.3%) | 2 (1.3%) | 6 (3.6%) | 2 (1.2%) | |
Cough | 2 (13.3%) | 4 (2.6%) | 6 (3.6%) | |||
Haematochezia | 0 (0%) | 3 (2%) | 3 (1.8%) | |||
Abdominal Pain | 0 (0%) | 3 (2%) | 3 (1.8%) | |||
Oedema | 0 (0%) | 3 (2%) | 3 (1.8%) | |||
Epistaxis | 1 (6.7%) | 1 (0.7%) | 2 (1.2%) |
Pyrotinib-related adverse events (AEs) includes definitely related AEs and probably related AEs.