Table 6 Laboratory parameters (means ± standard deviation) in the ITT population.
Group | Baseline | Exposure | Exposure | Exposure | Follow-up | |
|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | |||
Hemoglobin (mg/dl) | IP | 14.0 ± 1.0 | 14.0 ± 0.9 | 13.9 ± 1.0 | 14.0 ± 0.9 | 14.0 ± 0.9 |
VM | 13.6 ± 1.1 | 13.7 ± 1.0 | 13.7 ± 1.0 | 13.5 ± 1.1 | 13.6 ± 1.1 | |
PL | 13.8 ± 0.9 | 13.8 ± 1.0 | 14.0 ± 1.1 | 13.8 ± 1.1 | 13.8 ± 1.1 | |
Hematocrit (%) | IP | 41.6 ± 2.6 | 41.7 ± 2.4 | 41.2 ± 2.6 | 41.4 ± 2.5 | 41.4 ± 2.1 |
VM | 40.7 ± 2.8 | 41.1 ± 2.7 | 40.7 ± 2.9 | 40.4 ± 3.1 | 40.5 ± 2.8 | |
PL | 41.4 ± 2.1 | 41.4 ± 2.5 | 41.8 ± 2.7 | 41.3 ± 2.7 | 41.4 ± 2.8 | |
Platelets (1000/μl) | IP | 272 ± 52 | 259 ± 43 | 271 ± 44 | 256 ± 41* | 250 ± 44 |
VM | 269 ± 46 | 272 ± 62 | 260 ± 59 | 251 ± 55* | 256 ± 65 | |
PL | 267 ± 56 | 265 ± 52 | 274 ± 66 | 271 ± 56 | 254 ± 52 | |
Calcium (mmol/l) | IP | 2.4 ± 0.0 | 2.4 ± 0.1 | 2.4 ± 0.0 | 2.4 ± 0.0 | 2.4 ± 0.0 |
VM | 2.3 ± 0.0 | 2.4 ± 0.1 | 2.4 ± 0.0 | 2.4 ± 0.0 | 2.4 ± 0.1 | |
PL | 2.4 ± 0.0 | 2.4 ± 0.0 | 2.4 ± 0.0 | 2.4 ± 0.0 | 2.4 ± 0.1 | |
Potassium (mmol/l) | IP | 4.3 ± 0.2 | 4.3 ± 0.4 | 4.3 ± 0.3 | 4.2 ± 0.3 | 4.2 ± 0.2 |
VM | 4.3 ± 0.3 | 4.1 ± 0.2 | 4.2 ± 0.2 | 4.2 ± 0.2 | 4.3 ± 0.2 | |
PL | 4.3 ± 0.2 | 4.2 ± 0.2 | 4.3 ± 0.3 | 4.3 ± 0.3 | 4.4 ± 0.4 | |
Sodium (mmol/l) | IP | 139 ± 2 | 139 ± 2 | 141 ± 2 | 140 ± 2 | 141 ± 2 |
VM | 139 ± 1 | 139 ± 2 | 141 ± 1 | 140 ± 2 | 140 ± 1 | |
PL | 138 ± 2 | 139 ± 1 | 141 ± 2 | 140 ± 2 | 141 ± 2 | |
Chloride (mmol/l) | IP | 101 ± 2 | 102 ± 2 | 103 ± 2 | 102 ± 2 | 102 ± 2 |
VM | 102 ± 2 | 102 ± 2 | 104 ± 1 | 103 ± 2 | 103 ± 2 | |
PL | 101 ± 2 | 102 ± 2 | 104 ± 2 | 103 ± 2 | 103 ± 2 | |
Creatinine (mg/dl) | IP | 0.8 ± 0.1 | 0.9 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 |
VM | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.8 ± 0.1 | |
PL | 0.8 ± 0.0 | 0.8 ± 0.1 | 0.8 ± 0.0 | 0.8 ± 0.1 | 0.8 ± 0.1 | |
Urea (mg/dl) | IP | 26 ± 6. | 28 ± 7 | 28 ± 8* | 27 ± 6 | 28 ± 6 |
VM | 26 ± 7 | 28 ± 8 | 28 ± 7* | 29 ± 8 | 27 ± 7 | |
PL | 30 ± 8 | 27 ± 6 | 26 ± 7 | 29 ± 8 | 30 ± 7 | |
Uric acid (mg/dl) | IP | 4.3 ± 1.0 | 4.5 ± 0.9 | 4.3 ± 1.1 | 4.3 ± 1.1 | 4.6 ± 1.1 |
VM | 4.2 ± 1.0 | 4.2 ± 0.8 | 4.1 ± 0.8 | 4.2 ± 0.9 | 4.2 ± 1.0 | |
PL | 4.3 ± 0.9 | 4.3 ± 1.1 | 4.3 ± 1.1 | 4.5 ± 1.3 | 4.6 ± 1.1 | |
AST (U/l) | IP | 26 ± 8 | 25 ± 7 | 25 ± 9 | 25 ± 7 | 26 ± 7 |
VM | 25 ± 6 | 23 ± 5 | 37 ± 60 | 25 ± 6 | 25 ± 7 | |
PL | 26 ± 7 | 24 ± 7 | 23 ± 6 | 23 ± 6 | 26 ± 10 | |
ALT (U/l) | IP | 20 ± 10 | 18 ± 7 | 16 ± 7 | 16 ± 7 | 17 ± 8 |
VM | 20 ± 9 | 17 ± 6** | 20 ± 16 | 17 ± 8 | 17 ± 8 | |
PL | 20 ± 10 | 21 ± 13 | 19 ± 16 | 18 ± 14 | 19 ± 12 | |
Gamma GT (U/l) | IP | 19 ± 9 | 18 ± 7 | 20 ± 9 | 19 ± 9 | 19 ± 9 |
VM | 15 ± 6 | 15 ± 6 | 15 ± 5 | 15 ± 5 | 14 ± 5 | |
PL | 19 ± 10 | 20 ± 11 | 21 ± 12 | 20 ± 12 | 18 ± 12 | |
Alkaline phosphatase (U/l) | IP | 63 ± 20 | 61 ± 20 | 64 ± 19 | 64 ± 18* | 63 ± 21 |
VM | 56 ± 17 | 56 ± 14 | 58 ±15 | 54 ± 12 | 54 ± 14 | |
PL | 59 ± 14 | 59 ± 17 | 58 ±16 | 57 ± 14 | 58 ± 19 | |
Bilirubin (mg/dl) | IP | 0.6 ± 0.2 | 0.6 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.1 | 0.6 ± 0.2 |
VM | 0.6 ± 0.3 | 0.7 ± 0.3 | 0.6 ± 0.3 | 0.7 ± 0.3* | 0.6 ± 0.3 | |
PL | 0.6 ± 0.3 | 0.6 ± 0.3 | 0.6 ± 0.5 | 0.6 ± 0.2 | 0.6 ± 0.3 | |
Total protein (g/dl) | IP | 7.7 ± 0.5 | 7.8 ± 0.4 | 7.7 ± 0.3 | 7.8 ± 0.4 | 7.8 ± 0.6 |
VM | 7.5 ± 0.3 | 7.8 ± 0.3 | 7.6 ± 0.3 | 7.6 ± 0.3 | 7.7 ± 0.3 | |
PL | 7.6 ± 0.2 | 7.7 ± 0.2 | 7.7 ± 0.3 | 7.7 ± 0.3 | 7.6 ± 0.3 | |
Albumin (g/dl) | IP | 4.7 ± 0.3 | 4.7 ± 0.2 | 4.7 ± 0.2 | 4.7 ± 0.2 | 4.7 ± 0.3 |
VM | 4.6 ± 0.2 | 4.7 ± 0.2 | 4.7 ± 0.2 | 4.6 ± 0.2 | 4.6 ± 0.2 | |
PL | 4.6 ± 0.2 | 4.7 ± 0.2 | 4.6 ± 0.3 | 4.6 ± 0.2 | 4.5 ± 0.3 | |
Lactate Dehydrogenase (U/l) | IP | 185 ± 23 | 179 ± 26 | 189 ± 36 | 200 ± 32 | 189 ± 34 |
VM | 180 ± 30 | 172 ± 35 | 184 ± 78 | 179 ± 37 | 184 ± 34 | |
PL | 191 ± 24 | 186 ± 32 | 180 ± 29 | 191 ± 28 | 197 ± 26 | |
Creatine kinase (U/l) | IP | 124 ± 78 | 126 ± 70 | 149 ± 192 | 152 ± 113 | 141 ± 107 |
VM | 118 ± 89 | 139 ± 114 | 657 ± 2556 | 134 ± 75 | 127 ± 112 | |
PL | 163 ± 225 | 140 ± 212 | 112 ± 83 | 126 ± 89 | 197 ± 379 | |
Amylase (U/l) | IP | 31 ± 8 | 31 ± 9 | 30 ± 9 | 30 ± 8 | 30 ± 8 |
VM | 35 ± 11 | 35 ± 12 | 34 ± 10 | 33 ± 11 | 34 ± 11 | |
PL | 35 ± 9 | 34 ± 8 | 34 ± 8 | 33 ± 7 | 32 ± 8 | |
Glucose (mg/dl) | IP | 89 ± 18 | 81 ± 12* | 84 ± 14 | 82 ± 12 | 83 ± 13 |
VM | 89 ± 16 | 82 ± 10 | 83 ± 9 | 85 ± 11 | 85 ± 16 | |
PL | 81 ± 10 | 89 ± 18 | 86 ± 19 | 85 ± 20 | 89 ± 15 | |
Cholesterol (mg/dl) | IP | 178 ± 27 | 192 ± 26 | 177 ± 26 | 176 ± 26 | 192 ± 29 |
VM | 178 ± 25 | 194 ± 32 | 183 ± 29 | 185 ± 28 | 193 ± 26 | |
PL | 191 ± 44 | 200 ± 48 | 194 ± 48 | 192 ± 45 | 203 ± 43 | |
Triglycerides (mg/dl) | IP | 116 ± 86 | 117 ± 68 | 108 ± 71 | 121 ± 101 | 109 ± 73 |
VM | 86 ± 33 | 94 ± 38 | 87 ± 46 | 87 ± 40 | 86 ± 32 | |
PL | 123 ± 65 | 120 ± 52 | 121 ± 56 | 110 ± 48 | 124 ± 66 | |
Thromboplastin time (sec) | IP | 30 ± 3 | nd | nd | nd | 30 ± 3 |
VM | 30 ± 3 | nd | nd | nd | 30 ± 3 | |
PL | 31 ± 3 | nd | Nd | nd | 30 ± 4 | |
Prothrombin time (%) | IP | 106 ± 13 | nd | nd | nd | 105 ± 11* |
VM | 108 ± 12 | nd | nd | nd | 108 ± 10 | |
PL | 107 ± 11 | nd | nd | nd | 109 ± 11 |