Global rating forms, the tool that program directors use most frequently to document residents' competence, may not be adequate to assess the six general competencies. The results are consistent with earlier published research indicating that physicians view competence in just two broad dimensions, which questions the premise of the six ACGME competencies. Further research is needed to validate and measure six distinct dimensions of clinical competence.
Background: Pembrolizumab plus axitinib improved efficacy over sunitinib in treatment-naive advanced renal cell carcinoma in the KEYNOTE-426 (NCT02853331) study. However, a relatively high incidence of grade 3/4 aminotransferase elevations was observed. Objective: To further characterize treatment-emergent aminotransferase elevations in patients treated with pembrolizumab-axitinib. Design, setting, and participants: Patients enrolled in KEYNOTE-426 were included in this study. Outcome measurements and statistical analysis: Three Standardized MedDRA Queries for potential hepatic disorders were used to identify patients for the hepatic event analysis subpopulation (HEAS). Alanine aminotransferase events were characterized for time to onset, time to recovery, corticosteroid use, and rechallenge with study treatment(s). Results and limitations: The HEAS comprised 189/429 (44%) pembrolizumabaxitinib patients and 128/425 (30%) sunitinib patients. Grade 3/4 hepatic adverse events were more common in the combination arm: 22% (94/429) versus 7% (29/ 425); 3% (13/429) discontinued the combination due to hepatic adverse events. In the pembrolizumab-axitinib arm, 125/426 patients (29%) had alanine aminotrans-* Corresponding author.
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