Table 3.
AE Summary in All Patients as Treated
| Events | Pembrolizumab Plus Chemotherapy n = 65 | Placebo Plus Chemotherapy n = 60 | ||
|---|---|---|---|---|
| Treatment-related AE, n (%) | 65 (100.0) | 60 (100.0) | ||
| Grades 3–5 | 53 (81.5) | 49 (81.7) | ||
| Leading to treatment discontinuation | ||||
| Any treatment | 8 (12.3) | 1 (1.7) | ||
| All treatmentsa | 1 (1.5) | 1 (1.7) | ||
| Led to deathb | 1 (1.5) | 1 (1.7) | ||
| Treatment-related AEs occurring in ≥20% of patients in either treatment group, n (%) | Any grade | Grades 3–5 | Any grade | Grades 3–5 |
| Decreased white blood cell count | 51 (78.5) | 23 (35.4) | 42 (70.0) | 12 (20.0) |
| Alopecia | 50 (76.9) | 0 | 39 (65.0) | 0 |
| Decreased neutrophil count | 50 (76.9) | 40 (61.5) | 43 (71.7) | 34 (56.7) |
| Anemia | 39 (60.0) | 3 (4.6) | 42 (70.0) | 6 (10.0) |
| Hypesthesia | 29 (44.6) | 0 | 22 (36.7) | 0 |
| Decreased appetite | 24 (36.9) | 0 | 18 (30.0) | 1 (1.7) |
| Increased alanine aminotransferase | 23 (35.4) | 0 | 15 (25.0) | 1 (1.7) |
| Nausea | 23 (35.4) | 0 | 10 (16.7) | 0 |
| Arthralgia | 19 (29.2) | 1 (1.5) | 11 (18.3) | 0 |
| Increased aspartate aminotransferase | 17 (26.2) | 0 | 11 (18.3) | 1 (1.7) |
| Decreased platelet count | 16 (24.6) | 5 (7.7) | 22 (36.7) | 4 (6.7) |
| Rash | 16 (24.6) | 0 | 3 (5.0) | 0 |
| Immune-mediated AEs and infusion reactions, n (%) | 22 (33.8) | 5 (7.7)c | 6 (10.0) | 1 (1.7)c |
| Hyperthyroidism | 11 (16.9) | 0 | 1 (1.7) | 0 |
| Hypothyroidism | 9 (13.8) | 1 (1.5) | 1 (1.7) | 0 |
| Pneumonitis | 6 (9.2) | 0 | 1 (1.7) | 0 |
| Type 1 diabetes mellitus | 3 (4.6) | 3 (4.6) | 0 | 0 |
| Infusion reactions | 2 (3.1) | 0 | 2 (3.3) | 1 (1.7) |
| Thyroiditis | 2 (3.1) | 0 | 0 | 0 |
| Colitis | 1 (1.5) | 1 (1.5) | 0 | 0 |
| Myositis | 0 | 0 | 1 (1.7) | 0 |
AE, adverse event.
a
Includes patients who discontinued pembrolizumab or placebo, carboplatin, and paclitaxel owing to an AE.
b
AEs leading to death that were attributed to the study treatment by the investigator(s) were pneumonia (n = 1) in the pembrolizumab–chemotherapy group and gastrointestinal perforation (n = 1) in the placebo–chemotherapy group.
c
There were no deaths owing to immune-mediated AEs and infusion reactions.