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Table 5 Summary of participants with PCSA (parameters with PCSA definitions) for clinical chemistry and haematology parameters during the single dose study

From: Phase I randomized dose-ascending placebo-controlled trials of ferroquine - a candidate anti-malarial drug - in adults with asymptomatic Plasmodium falciparum infection

Laboratory blood parameters (PCSA definition) Normal range Single Dose Study
   Placebo Ferroquine
   (N = 10) 400 mg (N = 6) 800 mg (N = 6) 1200 mg (N = 6) 1400 mg (N = 6) 1600 mg (N = 6)
Eosinophils (> max (0.5 Giga/L, ULN)) 0-1320/μl 6 5 1 3 6 5
Haemoglobin (decrease2 g/dL versus baseline) 10.0-16.5 g/dL 1 0 4 1 0 0
Neutrophils (<1.0 Giga/L, Black) 1400-8140/μL 4 3 2 1 1 4
Platelets (<100 Giga/L) 120-400 Giga/L 0 0 0 0 0 0
White Blood Cells (<2 Giga/L, Black) 3.5-11/μL 0 1 1 0 0 0
ALT (PCSA >2 ULN) < 45 U/L 0 1 1 0 0 0
AST (PCSA >2 ULN) < 45 U/L 0 1 1 0 0 2
Alkaline phosphatase (>1.5 ULN) 13 - 100 U/L 0 0 1 0 0 0
CPK (3 ULN) 25-90 U/L 1 0 2 2 1 1
Creatinine (150 μmol/L, adults) <133 μmol/L 1 0 1 0 0 1
Gamma GT (3 ULN) <50 U/L 0 0 1 0 0 0
Glucose (≤ 2.5 mmol/L) 3.6-6.1 mmol/L 0 0 0 0 1 1
Glucose (2 mmol/L, fasted) 3.6-6.1 mmol/L 1 0 0 0 0 0
Potassium (< 3 mmol/L) 3.5-5.0 mmol/L 0 1 0 0 0 0
Potassium (5.5 mmol/L) 3.5-5.0 mmol/L 0 0 0 0 1 1
Total bilirubin (34 μmol/L) 0-17 μmol/L 1 1 0 0 0 0
Total cholesterol (7.74 mmol/L) 120-240 mg/dL 0 0 0 0 0 0
Triglycerides (4.6 mmol/L) 0-200 mg/dL 0 0 0 0 0 0
  1. NOTE: N: count of patients; PCSA: Potentially Clinically Significant Abnormality (version 2.2, December 2004); LLN/ULN: Lower/Upper Limit of Normality. For hemoglobin, baseline values <LLN or >ULN are counted normal; for eosinophils, values <LLN are counted as normal. For ALT, AST, ALP, Total Bilirubin, GGT, CPK, baseline values <LLN are counted normal