You are viewing the site in preview mode

Skip to main content

Advertisement

Table 2 Any-grade TRAEs occurring in ≥10% of patients or grade ≥3 in any patient and infusion-related reactions in the first-line switch-maintenance or second-line subgroup

From: Avelumab (anti–PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial

Patients, n (%) 1 L-mn subgroup (n = 90) 2 L subgroup (n = 60)
Any grade Grade 3 Grade 4 Grade 5 Any grade Grade 3 Grade 4 Grade 5
Any TRAEa 57 (63.3) 7 (7.8) 0 1 (1.1) 28 (46.7) 3 (5.0) 2 (3.3) 0
 Fatigue 10 (11.1) 2 (2.2) 0 0 5 (8.3) 0 0 0
 Decreased appetite 3 (3.3) 0 0 0 2 (3.3) 1 (1.7) 0 0
 Asthenia 1 (1.1) 0 0 0 3 (5.0) 2 (3.3) 0 0
 Colitis 2 (2.2) 1 (1.1) 0 0 0 0 0 0
 Elevated amylase 2 (2.2) 0 0 0 1 (1.7) 1 (1.7) 0 0
 Elevated lipase 2 (2.2) 1 (1.1) 0 0 1 (1.7) 0 1 (1.7) 0
 Elevated γ-glutamyltransferase 2 (2.2) 1 (1.1) 0 0 0 0 0 0
 Anemia 1 (1.1) 1 (1.1) 0 0 1 (1.7) 1 (1.7) 0 0
 Decreased platelet count 1 (1.1) 1 (1.1) 0 0 1 (1.7) 0 1 (1.7) 0
 Abdominal pain 1 (1.1) 1 (1.1) 0 0 0 0 0 0
 Adrenal insufficiency 1 (1.1) 0 0 0 1 (1.7) 1 (1.7) 0 0
 Autoimmune hepatitisb 1 (1.1) 0 0 1 (1.1) 0 0 0 0
 Decreased hemoglobin 1 (1.1) 1 (1.1) 0 0 0 0 0 0
 Hepatic failureb 1 (1.1) 0 0 1 (1.1) 0 0 0 0
 Hyperglycemia 1 (1.1) 1 (1.1) 0 0 0 0 0 0
 Hypokalemia 1 (1.1) 1 (1.1) 0 0 0 0 0 0
 Peripheral motor neuropathy 1 (1.1) 1 (1.1) 0 0 0 0 0 0
Infusion-related reactionc 20 (22.2) 1 (1.0) 0 0 11 (18.3) 0 0 0
  1. aThe incidence of treatment-related infusion-related reaction based on the single MedDRA preferred term is not listed
  2. bOccurred in the same patient
  3. cIncludes adverse events categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs and symptoms of infusion-related reaction that occurred on the same day of infusion and resolved within 2 days (including adverse events classified by investigators as related or unrelated to treatment)
  4. 1 L-mn first-line switch-maintenance, 2 L second line, TRAE treatment-related adverse event