Table 3.
TRAEs of any grade and grade 3 or 4 occurring in > 5% of patients in either treatment group (APaT population)
| TRAEs, n (%) | Pembrolizumab N = 30 |
Chemotherapy N = 22 |
||
|---|---|---|---|---|
| Any grade | Grade 3–5 | Any grade | Grade 3–5 | |
| Any | 17 (56.7) | 5 (16.7) | 21 (95.5) | 17 (77.3) |
| Alopecia | – | – | 12 (54.5) | – |
| Decreased white blood cell count | – | – | 9 (40.9) | 8 (36.4) |
| Decreased appetite | 1 (3.3) | 9 (40.9) | 1 (4.5) | |
| Decreased neutrophil count | – | – | 8 (36.4) | 7 (31.8) |
| Nausea | 3 (10.0) | – | 8 (36.4) | – |
| Peripheral sensory neuropathy | – | – | 8 (36.4) | – |
| Anemia | – | – | 7 (31.8) | 4 (18.2) |
| Neutropenia | – | – | 7 (31.8) | 6 (27.3) |
| Fatigue | 2 (6.7) | – | 8 (36.4) | 2 (9.1) |
| Malaise | 3 (10.0) | – | 5 (22.7) | – |
| Pruritus | 6 (20.0) | – | 2 (9.1) | – |
| Stomatitis | 1 (3.3) | 1 (3.3) | 4 (18.2) | – |
| Diarrhea | 1 (3.3) | – | 4 (18.2) | – |
| Dysgeusia | – | – | 4 (18.2) | – |
| Decreased lymphocyte count | 1 (3.3) | 1 (3.3) | 3 (13.6) | 3 (13.6) |
| Hiccups | – | – | 3 (13.6) | – |
| Rash | 4 (13.3) | 1 (3.3) | 1 (4.5) | – |
| Hypothyroidism | 4 (13.3) | – | – | – |
| Upper abdominal pain | 1 (3.3) | – | 2 (9.1) | – |
| Febrile neutropenia | – | – | 2 (9.1) | 2 (9.1) |
| Hyperkalemia | – | – | 2 (9.1) | 2 (9.1) |
| Hyponatremia | – | – | 2 (9.1) | 2 (9.1) |
| Leukopenia | – | – | 2 (9.1) | 2 (9.1) |
| Nail discoloration | – | – | 2 (9.1) | – |
| Constipation | – | – | 2 (9.1) | – |
| Peripheral edema | – | – | 2 (9.1) | – |
| Interstitial lung disease | 2 (6.7) | 1 (3.3) | 1 (4.5) | – |
| Hyperthyroidism | 2 (6.7) | – | – | – |
| Pyrexia | 2 (6.7) | – | 1 (4.5) | – |
APaT all patients as treated, TRAE treatment-related adverse event