The most commonly occurring (≥3%) TEAEs by preferred term were hyperlipidemia, hyperuricemia, diabetic ketosis, ketosis, and hypoglycemia in the system organ class (SOC) of metabolism and nutrition disorders; urine ketone body present, blood parathyroid hormone (PTH) increased, and white blood cells urine positive in the SOC of investigations; and urinary tract infection and upper respiratory tract infection in the SOC of infections and infestations. The gene discussed is PTH; the disease is urinary tract infection.