Table 3.
Adverse events related to treatment in patients who received sintilimab or placebo in combination with chemotherapy
| Sintilimab and chemotherapy (n=327) | Placebo and chemotherapy (n=332) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Grades 1-2 | Grade 3 | Grade 4 | Grade 5 | Grades 1-2 | Grade 3 | Grade 4 | Grade 5 | ||
| Any adverse events related to treatment* | 125 (38) | 134 (41) | 53 (16) | 9 (3) | 145 (44) | 122 (37) | 53 (16) | 6 (2) | |
| Anaemia | 204 (62) | 41 (13) | 0 | 0 | 198 (60) | 34 (10) | 0 | 0 | |
| Decrease in white blood cell count | 153 (47) | 44 (13) | 13 (4) | 0 | 143 (43) | 51 (15) | 23 (7) | 0 | |
| Nausea | 146 (45) | 7 (2) | 0 | 0 | 165 (50) | 6 (2) | 0 | 0 | |
| Vomiting | 105 (32) | 7 (2) | 0 | 0 | 106 (32) | 5 (2) | 0 | 0 | |
| Decrease in neutrophil count | 104 (32) | 61 (19) | 37 (11) | 0 | 89 (27) | 73 (22) | 39 (12) | 0 | |
| Alopecia | 98 (30) | 1 (<1) | 0 | 0 | 88 (27) | 0 | 0 | 0 | |
| Asthenia | 96 (29) | 13 (4) | 0 | 0 | 78 (23) | 12 (4) | 0 | 0 | |
| Decreased appetite | 90 (28) | 0 | 0 | 0 | 105 (32) | 2 (<1) | 1 (<1) | 0 | |
| Hypoaesthesia | 73 (22) | 2 (<1) | 0 | 0 | 49 (15) | 0 | 0 | 0 | |
| Decrease in platelet count | 60 (18) | 6 (2) | 2 (<1) | 1 (<1) | 73 (22) | 6 (2) | 3 (<1) | 1 (<1) | |
| Decrease in weight | 53 (16) | 3 (<1) | 0 | 0 | 55 (17) | 0 | 0 | 0 | |
| Hypothyroidism | 48 (15) | 0 | 0 | 0 | 28 (8) | 1 (<1) | 0 | 0 | |
| Rash | 45 (14) | 4 (1) | 1 (<1) | 0 | 14 (4) | 0 | 0 | 0 | |
| Diarrhoea | 37 (11) | 4 (1) | 0 | 0 | 27 (8) | 2 (<1) | 0 | 0 | |
| Increase in alanine aminotransferase | 35 (11) | 1 (<1) | 0 | 0 | 16 (5) | 1 (<1) | 0 | 0 | |
| Hypophagia | 33 (10) | 0 | 0 | 0 | 24 (7) | 1 (<1) | 1 (<1) | 0 | |
| Decrease in lymphocyte count | 30 (9) | 8 (2) | 2 (<1) | 0 | 25 (8) | 13 (4) | 0 | 0 | |
| Hypokalaemia | 22 (7) | 14 (4) | 2 (<1) | 0 | 25 (8) | 5 (2) | 1 (<1) | 0 | |
| Hyponatraemia | 17 (5) | 3 (<1) | 3 (<1) | 0 | 34 (10) | 2 (<1) | 1 (<1) | 0 | |
| Abnormal hepatic function | 11 (3) | 5 (2) | 1 (<1) | 0 | 12 (4) | 0 | 0 | 0 | |
| Neurotoxicity | 8 (2) | 0 | 0 | 0 | 9 (3) | 4 (1) | 0 | 0 | |
| Immune mediated lung disease | 7 (2) | 4 (1) | 0 | 3 (<1) | 1 (<1) | 0 | 0 | 0 | |
| Increase in blood pressure | 5 (2) | 10 (3) | 0 | 0 | 4 (1) | 4 (1) | 0 | 0 | |
| Pneumonia | 2 (<1) | 6 (2) | 1 (<1) | 3 (<1) | 6 (2) | 1 (<1) | 0 | 3 (<1) | |
| Febrile neutropenia | 0 | 3 (<1) | 5 (2) | 0 | 0 | 4 (1) | 2 (<1) | 0 | |
| Acute kidney injury | 0 | 4 (1) | 0 | 0 | 1 (<1) | 1 (<1) | 0 | 0 | |
Data are number (%).
Chemotherapy regimen is cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil.
Adverse events related to treatment of grades 1-2 occurring in ≥10% of patients or grades 3-5 occurring in ≥1% of patients are shown. Adverse events related to treatment included any study drug. Patients who died because of adverse events related to treatment had immune mediated lung disease (n=2), immune mediated lung disease and pneumonia (n=1), pneumonitis and pneumonia (n=1), pneumonia, septic shock, and myelosuppression (n=1), arrhythmia (n=1), decrease in platelet count and cerebral haemorrhage (n=1), cardiac failure, respiratory failure, renal failure, and septic shock (n=1), and unknown cause of death (n=1) in the sintilimab-chemotherapy group, and pneumonia (n=3), unknown cause of death (n=2), and immune mediated myositis, immune mediated myocarditis, and decreased platelet count (n=1) in the placebo-chemotherapy group.