Adverse Events | PD-1/PD-L1 inhibitor plus carboplatin-paclitaxel no. (%) | Carboplatin-paclitaxel chemotherapy-based no. (%) | ||
---|---|---|---|---|
(n = 713) | (n = 718) | |||
(n = 79) | Any Grade n(%) | ≥ 3 Grade n(%) | Any Grade n(%) | ≥ 3 Grade n(%) |
General disorders and administration site conditions | ||||
Fatigue | 414 (58.06) | 7 (0.98) | 386 (53.76) | 3 (0.42) |
Anemia | 340 (47.69) | 104 (14.59) | 339 (47.21) | 82 (11.42) |
Infusion related reaction | 61 (8.55) | 8 (1.12) | 51 (7.10) | 10 (1.39) |
Decreased appetite | 52 (7.29) | 0 | 43 (5.99) | 0 |
Weight loss | 35 (4.91) | 2 (0.28) | 27 (3.76) | 3 (0.42) |
Fever | 14 (1.96) | 0 | 9 (1.25) | 1 (0.14) |
Generalized Pain | 3 (0.42) | 0 | 5 (0.70) | 1 (0.14) |
Nervous system disorders | ||||
Peripheral sensory neuropathy | 344 (48.25) | 9 (1.26) | 346 (48.19) | 6 (0.84) |
Paresthesia | 17 (2.38) | 2 (0.28) | 26 (3.62) | 1 (0.14) |
Stroke | 1 (0.14) | 1 (0.14) | 1 (0.14) | 1 (0.14) |
Vasovagal reaction | 1 (0.14) | 1 (0.14) | 0 | 0 |
Cardiovascular system disorders | ||||
Hypertension | 71 (9.96) | 27 (3.79) | 61 (8.50) | 11 (1.53) |
Supraventricular tachycardia | 0 | 0 | 1 (0.14) | 1 (0.14) |
Cardiac disorders (other) | 1 (0.14) | 1 (0.14) | 0 | 0 |
Vascular disorders | ||||
Pulmonary embolism | 6 (0.84) | 6 (0.84) | 5 (0.70) | 5 (0.70) |
Thromboembolic event | 6 (0.84) | 1 (0.14) | 2 (0.28) | 0 |
Hot flashes | 1 (0.14) | 1 (0.14) | 2 (0.28) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Dyspnea | 134 (18.79) | 14 (1.96) | 124 (17.27) | 2 (0.28) |
Pneumonitis | 5 (0.70) | 2 (0.28) | 3 (0.42) | 1 (0.14) |
Gastrointestinal disorders | ||||
Nausea | 330 (46.28) | 7 (0.98) | 294 (40.95) | 5 (0.70) |
Constipation | 266 (37.31) | 5 (0.70) | 246 (34.26) | 3 (0.42) |
Diarrhea | 234 (32.82) | 12 (1.68) | 207 (28.83) | 4 (0.56) |
Vomiting | 86 (12.06) | 5 (0.70) | 54 (7.52) | 5 (0.70) |
Colitis | 11 (1.54) | 0 | 4 (0.56) | 1 (0.14) |
Pyrexia | 6 (0.84) | 6 (0.84) | 2 (0.28) | 2 (0.28) |
Abdominal pain | 7 (0.98) | 2 (0.28) | 3 (0.42) | 0 |
Pancreatitis | 1 (0.14) | 0 | 4 (0.56) | 0 |
Mucositis oral | 2 (0.28) | 0 | 3 (0.42) | 0 |
Ascites | 1 (0.14) | 1 (0.14) | 0 | 0 |
Hepatic Failure | 1 (0.14) | 1 (0.14) | 0 | 0 |
Colonic obstruction | 0 | 0 | 1 (0.14) | 1 (0.14) |
Renal and urinary disorders | ||||
Urinary tract infection | 4 (0.56) | 4 (0.56) | 7 (0.97) | 5 (0.70) |
Acute Kidney Injury | 7 (0.98) | 7 (0.98) | 3 (0.42) | 3 (0.42) |
Urinary tract obstruction | 1 (0.14) | 1 (0.14) | 0 | 0 |
Bladder infecction | 1 (0.14) | 0 | 1 (0.14) | 0 |
Skin and subcutaneous tissue disorders | ||||
Alopecia | 145 (20.34) | 0 | 149 (20.75) | 0 |
Rash | 125 (17.53) | 7 (0.98) | 77 (10.72) | 4 (0.56) |
Pruritus | 5 (0.70) | 1 (0.14) | 2 (0.28) | 0 |
Erythema multiforme | 2 (0.28) | 1 (0.14) | 1 (0.14) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 191 (26.79) | 3 (0.42) | 203 (28.27) | 3 (0.42) |
Myalgia | 137 (19.21) | 2 (0.28) | 133 (18.52) | 5 (0.70) |
Asthenia | 2 (0.28) | 2 (0.28) | 6 (0.84) | 6 (0.84) |
Muscular weakness | 5 (0.70) | 5 (0.70) | 1 (0.14) | 1 (0.14) |
Myositis | 2 (0.28) | 0 | 1 (0.14) | 1 (0.14) |
Bone pain | 1 (0.14) | 0 | 3 (0.42) | 0 |
Musculoskeletal and connective tissue disorders (other) | 1 (0.14) | 1 (0.14) | 0 | 0 |
Endocrine system disorders | ||||
Hypothyroidism | 112 (15.71) | 27 (3.78) | 79 (11.00) | 7 (0.97) |
Hyperthyroidism | 26 (3.65) | 0 | 11 (1.53) | 0 |
Adrenal Insuffiency | 4 (0.56) | 0 | 1 (0.14) | 0 |
Hypophysitis | 2 (0.28) | 2 (0.28) | 0 | 0 |
Metabolism and nutrition disorders | ||||
Hypomagnesemia | 52 (7.29) | 0 | 70 (9.75) | 0 |
Hypokalemia | 12 (1.68) | 0 | 9 (1.25) | 0 |
Hyperglycaemia | 5 (0.70) | 2 (0.28) | 2 (0.28) | 0 |
Anorexia | 2 (0.28) | 1 (0.14) | 5 (0.70) | 0 |
Hypertriglyceridemia | 4 (0.56) | 1 (0.14) | 0 | 0 |
Hypercalcemia | 2 (0.28) | 0 | 2 (0.28) | 0 |
Glucose Intolerance | 2 (0.28) | 0 | 0 | 0 |
Reproductive system and breast disorders | ||||
Uterine hemorrhage | 4 (0.56) | 0 | 1 (0.14) | 1 (0.14) |
Pelvic pain | 1 (0.14) | 1 (0.14) | 2 (0.28) | 0 |
Vaginal hemorrhage | 2 (0.28) | 1 (0.14) | 0 | 0 |
Reproductive system and breast disorders (other) | 1 (0.14) | 1 (0.14) | 0 | 0 |
Blood and lymphatic system disorders | Â | Â | Â | Â |
Neutropenia or Neutrophil count decreased | 154 (21.60) | 110 (15.43) | 172 (23.96) | 104 (14.48) |
Thrombocytopenia | 137 (19.21) | 20 (2.80) | 106 (14.76) | 9 (1.25) |
White blood cell decreased | 36 (5.05) | 23 (3.23) | 30 (4.17) | 21 (2.92) |
Alanine aminotransferase increased | 22 (3.08) | 1 (0.14) | 4 (0.56) | 0 |
Platelet count decreased | 16 (2.24) | 5 (0.70) | 17 (2.37) | 3 (0.42) |
Alkaline phosphatase increased | 6 (0.84) | 3 (0.42) | 1 (0.14) | 0 |
Aspartate aminotransferase increased | 7 (0.98) | 1 (0.14) | 2 (0.28) | 0 |
Creatinine increased | 4 (0.56) | 0 | 4 (0.56) | 1 (0.14) |
Gamma-glutamyl transferase increased | 5 (0.70) | 1 (0.14) | 2 (0.28) | 0 |
Blood bilirubin increased | 2 (0.28) | 1 (0.14) | 0 | 0 |
Leukocytosis | 0 | 0 | 1 (0.14) | 1 (0.14) |
Immune system disorders | ||||
Allergic reaction | 8 (1.12) | 4 (0.56) | 6 (0.84) | 1 (0.14) |
Immune system disorders (other) | 1 (0.14) | 1 (0.14) | 0 | 0 |
Infections and infestations | ||||
Tooth infection | 1 (0.14) | 1 (0.14) | 0 | 0 |
Wound complication | 1 (0.14) | 1 (0.14) | 0 | 0 |
Infections and infestations (other) | 5 (0.70) | 2 (0.28) | 2 (0.28) | 0 |