TRAEs | Any grade n (%) | Grade 1–2 n | Grade 3–4 n | Grade 5 n | |
Any | 30 (100) | 30 | 21 | 1 | |
Dermatitis/rash | 24 (80) | 22 | 2 | 0 | |
Appetite loss/nausea/vomiting | 21 (70) | 19 | 2 | 0 | |
Anemia | 21 (70) | 19 | 2 | 0 | |
Fatigue | 18 (60) | 17 | 1 | 0 | |
Transaminitis/hepatitis | 17 (57) | 13 | 4 | 0 | |
Leukopenia | 17 (57) | 10 | 7 | 0 | |
Esophagitis | 16 (53) | 15 | 1 | 0 | |
Electrolyte disorders | 16 (53) | 15 | 1 | 0 | |
Constipation/diarrhea | 16 (53) | 16 | 0 | 0 | |
Thrombocytopenia | 14 (47) | 9 | 5 | 0 | |
Pain | 13 (43) | 13 | 0 | 0 | |
Alk Phos increased | 11 (37) | 11 | 0 | 0 | |
Thyroid disorders | 10 (33) | 10 | 0 | 0 | |
Dyspnea | 10 (33) | 7 | 3 | 0 | |
Cough | 10 (33) | 10 | 0 | 0 | |
GGT increased | 8 (27) | 6 | 2 | 0 | |
Fever | 6 (20) | 6 | 0 | 0 | |
Nervous disorders | 5 (17) | 5 | 0 | 0 | |
Lymphopenia | 5 (17) | 4 | 1 | 0 | |
LDH increased | 5 (17) | 5 | 0 | 0 | |
Pneumonitis | 4 (13) | 2 | 1 | 1 | |
Dry skin | 4 (13) | 4 | 0 | 0 | |
Insomnia | 3 (10) | 3 | 0 | 0 | |
Infusion-related reaction | 3 (10) | 3 | 0 | 0 | |
CRP increased | 3 (10) | 3 | 0 | 0 | |
irAEs | |||||
Any | 20 (67) | 16 | 6 | 1 | |
Thyroid disorders | 10 (33) | 10 | 0 | 0 | |
Dermatitis/rash | 9 (30) | 7 | 2 | 0 | |
Pneumonitis | 3 (10) | 2 | 0 | 1 | |
Transaminitis/hepatitis | 2 (7) | 0 | 2 | 0 | |
Pericarditis | 1 (3) | 1 | 0 | 0 | |
Pancreatitis | 1 (3) | 0 | 1 | 0 | |
Myositis | 1 (3) | 0 | 1 | 0 | |
Allergic reaction | 1 (3) | 1 | 0 | 0 |
TRAEs monitored in all 30 patients commencing with induction therapy, and occurring in 10% or more of patients, in the period from the start of therapy until 90 days post-surgery or if no surgery was performed until 180 days after the start of therapy, are shown in the top part. In the bottom part, irAEs are shown.
CRP, C-reactive protein; GGT, gamma glutamyl transferase; irAE, immune-related adverse events; LDH, lactate dehydrogenase; TRAE, treatment-related adverse events.