Table 2

Laboratory test results, ITT population

Category (normal cut-off value)Baseline,
mean (SD)
Month 6,
mean (SD)
Month 12,
mean (SD)
Month 24,
mean (SD)
p Value (baseline vs Month 24)
White blood cell count (3.5×109/L)
 Normal at baseline (×109/L)6.5 (2.12), n=2716.4 (2.02), n=2716.3 (2.08), n=2766.4 (2.14), n=2760.5173
 Abnormal (low) at baseline (×109/L)2.7 (0.51), n=943.7 (1.41), n=944.0 (1.19), n=944.1 (1.58), n=94<0.0001
Haemoglobin (male=13.5 g/dL, female=12 g/dL)
 Normal/high at baseline (g/dL)13.3 (0.90), n=17113.1 (1.03), n=17113.1 (0.99), n=17613.1 (1.02), n=1760.1051
 Abnormal (low) at baseline (g/dL)10.9 (0.95), n=19311.4 (1.01), n=19311.6 (1.06), n=19311.6 (1.13), n=193<0.0001
Platelet count (150×109/L)
 Normal/high at baseline (×109/L)262.5 (80.39), n=276252.7 (69.47), n=276251.9 (68.62), n=280250.5 (72.11), n=2800.0355
 Abnormal (low) at baseline (×109/L)105.0 (26.55), n=88131.8 (41.77), n=88145.8 (49.29), n=88155.9 (54.04), n=89<0.0001
ESR (male <50 years=15 mm/h, male ≥50 years and female <50 years=20 mm/h, female ≥50 years=30 mm/h)
 Normal/high at baseline (mm/h)12.7 (7.44), n=5613.9 (9.68), n=5612.5 (10.04), n=6010.0 (6.65), n=600.0225
 Abnormal (elevated) at baseline (mm/h)48.7 (20.98), n=27332.1 (17.4), n=27326.4 (16.86), n=27725.0 (17.56), n=280<0.0001
Serum creatinine (male=1.3 mg/dL, female=1.1 mg/dL)
 Normal/low at baseline (mg/dL)0.8 (0.18), n=2840.8 (0.19), n=2840.8 (0.18), n=2910.9 (0.22), n=2960.6660
 Abnormal (high) at baseline (mg/dL)1.6 (0.63), n=561.4 (0.53), n=561.3 (0.47), n=591.3 (0.48), n=59<0.0001
Spot urine protein–creatinine ratio (0.2 mg/mg)
 Normal at baseline (mg/mg)0.1 (0.04), n=400.1 (0.04), n=400.1 (0.05), n=410.1 (0.14), n=460.1880
 Abnormal (high/very high) at baseline (mg/mg)0.8 (0.78), n=410.7 (0.65), n=410.6 (0.71), n=530.5 (0.53), n=58<0.0001
24 h urine collection (normal to high 300 mg/24 h, high to very high 500 mg/24 h)
 Normal at baseline (mg/24 h)283.0 (0), n=1257.0 (0), n=1209.0 (0), n=1207 (132.28), n=30.7500
 Abnormal (high) at baseline (mg/24 h)417.8 (61.9), n=5450.0 (119.79), n=5714.3 (454.96), n=6688.3 (477.47), n=60.3125
 Abnormal (very high) at baseline (mg/24 h)1014.0 (466.9), n=4839.5 (225.7), n=41643.8 (1344.2), n=51466.9 (1242.3), n=71.0000
CRP (10 mg/L)
 Normal at baseline (mg/L)1.8 (1.68), n=2461.0 (1.07), n=2461.0 (1.97), n=2530.8 (0.9), n=2600.0156
 Abnormal (elevated) at baseline (mg/L)16.2 (4.77), n=77.6 (4.42), n=75.3 (7.34), n=75.3 (8.45), n=7<0.0001
AST (male=20 IU/L, female=36 IU/L)
 Normal/low at baseline (IU/L)21.8 (6.60), n=24323 (9.46), n=24323.2 (9.93), n=24823.8 (9.55), n=2480.0025
 Abnormal (high) at baseline (IU/L)43.9 (17.26), n=5632.6 (13.76), n=5633.2 (16.77), n=5931.2 (16.06), n=60<0.0001
ALT (male=45 IU/L, female=33 IU/L)
 Normal/low at baseline (IU/L)20.6 (6.70), n=23621.3 (7.93), n=23621.6 (9.23), n=24422.3 (8.69), n=2460.0159
 Abnormal (high) at baseline (IU/L)46.9 (15.44), n=7036.6 (17.31), n=7035 (18.13), n=7233.2 (17.71), n=73<0.0001
C3 complement (75 mg/dL)
 Normal/high at baseline (mg/dL)114.4 (30.03), n=142119.1 (28.98), n=142120.1 (27.90), n=148118.7 (28.68), n=1500.0244
 Abnormal (low) at baseline (mg/dL)53.3 (16.68), n=13670.3 (25.39), n=13680.2 (28.01), n=14282.2 (32.21), n=145<0.0001
C4 complement (male=12 mg/dL, female=13 mg/dL)
 Normal/high at baseline (mg/dL)25.5 (13.54), n=12226.9 (13.03), n=12226.7 (11.94), n=12827.6 (12.08), n=1300.0012
 Abnormal (low) at baseline (mg/dL)7.4 (3.04), n=15612.8 (7.46), n=15614.5 (7.60), n=16216.2 (9.20), n=165<0.0001
  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; ITT, intent-to treat.