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Table 1 Participant demographic and baseline characteristics

From: Long-term safety and efficacy of pegvaliase for the treatment of phenylketonuria in adults: combined phase 2 outcomes through PAL-003 extension study

  Phase 2 participants (N = 80)
Age at enrollment
 Mean (SD), years 28.3 (8.8)
 Min, max, years 16, 56
  < 18, n (%) 3 (3.8%)
  ≥ 18, n (%) 77 (96.3%)
Sex
 Female, n (%) 46 (57.5%)
Race
 White, n (%) 78 (97.5%)
Weight n = 79
 Mean (SD), kg 80.4 (24.5)
 Min, max, kg 42.0, 178.0
Height n = 74
 Mean (SD), cm 167.2 (9.6)
 Min, max, cm 149.8, 187.5
Body mass index n = 74
 Mean (SD), kg/m2 28.5 (7.7)
 Min, max, kg/m2 17.2, 56.2
  < 25 kg/m2, n (%) 28 (35.0%)
 25 to < 30 kg/m2, n (%) 21 (26.3%)
  ≥ 30 kg/m2, n (%) 25 (31.3%)
Plasma Phe
 Mean (SD), μmol/L 1302.4 (351.5)
 Min, max, μmol/L 249.0, 2214.0
Protein intakea n = 36
 Mean (SD), g/day 69.4 (40.0)
 Min, max, g/day 10.7, 197.3
Phe intakeb n = 36
 Mean (SD), mg/day 1975 (1583)
 Min, max, mg/day 461, 8419
  1. Baseline was defined as the last measurement before the first dose of pegvaliase (i.e., while patients were treatment naïve) in the parent study. All phase 2 data are included. Sample size is indicated if N < 80
  2. max maximum, min minimum, Phe phenylalanine, SD standard deviation
  3. aProtein intake includes medical food and natural protein dietary intake and was calculated as the daily average intake over 3 days prior to the assessment point
  4. bPhe intake was calculated as the daily average intake over 3 days prior to the assessment point