Safety
hypothyroidism, nausea, decreased white blood cell count, anemia
HYPOTHYROIDISM, ADVERSE EVENT, ANEMIA, INFUSION REACTION
Treatment‐related AEs occurred in all 61 patients (100%) and 26 patients (100%) in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups, respectively. The most common treatment‐related AEs in both treatment groups were decreased white blood cell count (pembrolizumab plus chemotherapy, 75%; placebo plus chemotherapy, 85%), decreased neutrophil count (72% and 81%), anemia (66% and 62%), and nausea (52% and 62%). Grade 3 or 4 treatment‐related AEs occurred in 52 patients (85%) in the pembrolizumab plus chemotherapy group and 22 (85%) in the placebo plus chemotherapy group. The most frequently occurring grade 3 or 4 treatment‐related AEs in the pembrolizumab plus chemotherapy group versus placebo plus chemotherapy group were decreased neutrophil count (59% vs. 62%), decreased white blood cell count (49% vs. 58%), and anemia (26% vs. 23%). Nineteen patients (31%) in the pembrolizumab plus chemotherapy group and four patients (15%) in the placebo plus chemotherapy group discontinued any treatment due to a treatment‐related AE. No patients in either group died due to a treatment‐related AE.Immune‐mediated AEs and infusion reactions of any grade occurred in 20 patients (33%) in the pembrolizumab plus chemotherapy group and four patients (15%) in the placebo plus chemotherapy group. The most frequently occurring immune‐mediated AEs (incidence ≥5%) in the pembrolizumab plus chemotherapy group were hypothyroidism (Summary of AEs in all treated patients.
Abbreviation: AE, adverse event.There were no grade 5 treatment‐related AEs, immune‐mediated AEs, or infusion reactions in either treatment group.