aFatigue is a composite term that includes fatigue, asthenia, and malaise.
bMusculoskeletal pain is a composite term that includes musculoskeletal pain, back pain, myalgia, and neck pain.
cRash is a composite term that includes rash, rash maculopapular, erythema, dermatitis acneiform, eczema, erythema multiforme, rash erythematous, rash macular, rash papular, rash pruritic, drug eruption, and lichen planus.
dUrinary tract infection is a composite term that includes urinary tract infection, urosepsis, cystitis, kidney infection, pyuria, pyelonephritis, bacteriuria, pyelonephritis acute, urinary tract infection bacterial, and Escherichia urinary tract infection.
eCough is a composite term that includes cough and productive cough.
PRIMARY
ANALYSIS3
TRARs (77.3% of patients)
irARs (29.4% of patients)
LONG-TERM
ANALYSIS2
TRARs (78.2% of patients)
irARs (32.3% of patients)
AR = Adverse reaction; BSC=best supportive care; irAR=immune-mediated adverse reaction; TRAR=treatment-related adverse reaction.
References: 1. Bavencio Prescribing Information. EMD Serono, Inc.; 2024. 2. Powles T, Park SH, Caserta C, et al. Avelumab first-line maintenance for advanced urothelial carcinoma: results from the JAVELIN Bladder 100 Trial after ≥2 years of follow-up. J Clin Oncol. 2023;41(19):3486-3492. 3. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230.