Table 3.
Treatment-Related AEs in Patients With and Without Brain Metastases (Pooled Safety Population)
| Treatment-Related AEs | With Brain Metastases |
Without Brain Metastases |
||
|---|---|---|---|---|
| Pembrolizumab (n = 196) | Chemotherapy (n = 90) | Pembrolizumab (n = 1743) | Chemotherapy (n = 1066) | |
| Any | 130 (66.3) | 76 (84.4) | 1172 (67.2) | 941 (88.3) |
| Grade ≥3 | 29 (14.8) | 41 (45.6) | 311 (17.8) | 460 (43.2) |
| Led to discontinuation of study treatment | 12 (6.1) | 9 (10.0) | 144 (8.3) | 117 (11.0) |
| Led to death | 3 (1.5) | 3 (3.3) | 22 (1.3) | 21 (2.0) |
| Affected the nervous system | 19 (9.7) | 24 (26.7) | 122 (7.0) | 283 (26.5) |
| Most common (≥2% in any group) | ||||
| Neuropathy peripheral | 1 (0.5) | 7 (7.8) | 9 (0.5) | 83 (7.8) |
| Dysgeusia | 3 (1.5) | 8 (8.9) | 23 (1.3) | 45 (4.2) |
| Peripheral sensory neuropathy | 1 (0.5) | 3 (3.3) | 12 (0.7) | 58 (5.4) |
| Paresthesia | 1 (0.5) | 5 (5.6) | 12 (0.7) | 34 (3.2) |
| Headache | 7 (3.6) | 3 (3.3) | 24 (1.4) | 11 (1.0) |
| Hypesthesia | 0 | 1 (1.1) | 3 (0.2) | 25 (2.3) |
| Immune-mediated AEs and infusion reactionsa | 41 (20.9) | 8 (8.9) | 440 (25.2) | 80 (7.5) |
| Grade 3−5 | 10 (5.1) | 1 (1.1) | 129 (7.4) | 17 (1.6) |
Note: AEs were graded on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Values are n (%) of patients.
AEs, adverse events.
a
Immune-mediated AEs were classified on the basis of a list of preferred terms identified by the sponsor as having an immune etiology. All immune-mediated AEs and infusion reactions are included, regardless of relationship to study drug.