Safety
diarrhea, TEAEs, anemia, hyperthyroidism, pruritus, Adverse drug reactions, Hypothyroidism
ADVERSE EVENTS, ADVERSE EVENT, EVENT, ANEMIA, MULTIPLE ORGAN DYSFUNCTION SYNDROME, HYPERTHYROIDISM, EVENTS, ADVERSE DRUG REACTION, HYPOTHYROIDISM
The most common AEs are summarized in Adverse events of the safety set.All values are shown as n (%).There were no TEAEs leading to serplulimab discontinuation. Four patients died of TEAEs and only 1 who had multiple organ dysfunction syndrome was deemed possibly related to the treatment. Eight (38.1%) patients with serious AEs were reported. Adverse drug reactions (ADRs), defined as events considered to have a causality with the investigational product, were reported in 19 (90.5%) patients. Seven (33.3%) had grade ≥3 ADR. There were no infusion-related reactions.Immune-related adverse events (irAEs) were observed in 12 (57.1%) patients, including 2 who experienced one or more grade ≥3 event. One of them had elevated blood creatine phosphokinase, while the other had diarrhea and anemia. Both cases were resolved quickly. Hypothyroidism (28.6%), hyperthyroidism (14.3%), and pruritus (14.3%) were the most common irAEs.