TABLE 2.
Safety Summary and TRAEs in All Treated Patients
| TRAE | Nivolumab Plus Chemotherapy (n = 141), No. (%) | Chemotherapy (n = 143), No. (%) | ||
|---|---|---|---|---|
| Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | |
| Any TRAEsa | 120 (85.1) | 63 (44.7) | 124 (86.7) | 42 (29.4) |
| TRAEs leading to discontinuationa | 21 (14.9) | 9 (6.4) | 11 (7.7) | 4 (2.8) |
| Serious TRAEsa | 27 (19.1) | 23 (16.3) | 13 (9.1) | 9 (6.3) |
| Treatment-related deathsb | 2 (1.4)c | 2 (1.4)d | ||
| Any TRAE occurring in ≥10% of patients in either treatment arm | ||||
| Anemia | 56 (39.7) | 22 (15.6) | 50 (35.0) | 13 (9.1) |
| Nausea | 44 (31.2) | 3 (2.1) | 50 (35.0) | 4 (2.8) |
| Decreased neutrophil count | 40 (28.4) | 16 (11.3) | 42 (29.4) | 16 (11.2) |
| Decreased WBC count | 36 (25.5) | 12 (8.5) | 34 (23.8) | 7 (4.9) |
| Increased ALT | 29 (20.6) | 6 (4.3) | 22 (15.4) | 3 (2.1) |
| Increased AST | 28 (19.9) | 0 | 23 (16.1) | 0 |
| Vomiting | 27 (19.1) | 4 (2.8) | 15 (10.5) | 1 (0.7) |
| Decreased appetite | 27 (19.1) | 3 (2.1) | 38 (26.6) | 3 (2.1) |
| Fatigue | 21 (14.9) | 3 (2.1) | 13 (9.1) | 1 (0.7) |
| Constipation | 19 (13.5) | 0 | 34 (23.8) | 0 |
| Decreased platelet count | 18 (12.8) | 7 (5.0) | 28 (19.6) | 4 (2.8) |
| Neutropenia | 16 (11.3) | 7 (5.0) | 5 (3.5) | 2 (1.4) |
| Increased blood creatinine | 15 (10.6) | 0 | 10 (7.0) | 0 |
| Pyrexia | 15 (10.6) | 0 | 3 (2.1) | 0 |
| Malaise | 13 (9.2) | 0 | 15 (10.5) | 0 |
Abbreviation: TRAE, treatment-related adverse event.
a
Includes patients with TRAEs reported between first dose and 30 days after last dose of study therapy.
b
Includes treatment-related deaths reported between first day and 100 days after last dose of study therapy.
c
One due to interstitial lung disease and one due to pneumonitis.
d
One due to interstitial lung disease and one due to pneumonia.