Table 3 Treatment-related adverse events in the neoadjuvant treatment period (the safety population) and in the adjuvant treatment period (the per-protocol population) and postoperative complications
Variable | Any grade | Grade 3 or 4 |
|---|---|---|
Neoadjuvant treatment period | ||
Any AEs | 45 (100.0) | 25 (55.6) |
White blood cell decreased | 35 (77.8) | 5 (11.1) |
Neutrophil count decreased | 34 (75.6) | 5 (11.1) |
Vomiting | 33 (73.3) | 4 (8.9) |
Alopecia | 30 (66.7) | 3 (6.7) |
Fatigue | 27 (60.0) | 2 (4.4) |
Anaemia | 22 (48.9) | 1 (2.2) |
Nausea | 19 (42.2) | 1 (2.2) |
Leg pain | 16 (35.6) | 2 (4.4) |
Peripheral sensory neuropathy | 15 (33.3) | 3 (6.7) |
Diarrhoea | 10 (22.2) | 1 (2.2) |
Bronchopulmonary haemorrhage | 2 (4.4) | – |
Rash | 5 (11.1) | 1 (2.2) |
Hypothyroidism | 2 (4.4) | 2 (4.4) |
Pneumonitis | 2 (4.4) | – |
Alanine aminotransferase increased | 1 (2.2) | 1 (2.2) |
Aspartate aminotransferase increased | 1 (2.2) | 1 (2.2) |
Blood bilirubin increased | 1 (2.2) | 1 (2.2) |
Oral mucositis oral | 1 (2.2) | 1 (2.2) |
Hyperthyroidism | 1 (2.2) | – |
Adjuvant treatment period | ||
irAEs | 14 (34.1) | 7 (17.1) |
Adrenal Insufficiency | 4 (9.8) | 2 (4.9) |
Fatigue | 4 (9.8) | 2 (4.9) |
Hypothyroidism | 4 (9.8) | 1 (2.4) |
Rash | 2 (4.9) | 1 (2.4) |
Fever | 2 (4.9) | 0 |
Pneumonitis | 1 (2.4) | 1 (2.4) |
Postoperative complications | ||
Any complications | 14 (34.1) | 8 (19.5) |
Pleural effusion | 6 (14.6) | 6 (14.6) |
Pneumonia | 5 (12.2) | 3 (7.3) |
Heart failure | 5 (12.2) | 0 |
Pneumothorax | 3 (7.3) | 3 (7.3) |
Intraoperative blood transfusion | 1 (2.4) | 0 |
Hoarseness | 1 (2.4) | 0 |
Respiratory failure | 0 | 0 |
Death within 30 and 90 days | 0 | 0 |
