Table 3.
Primary Outcome of Safety Assessments. Continuous Outcome Variable Results: Hematological and Biochemical Safety Laboratory Outcomes and Vital Signs
| 95% HPD Interval |
|||
|---|---|---|---|
| Variable | Mean | Lower Limit | Upper Limit |
| Hemoglobin (g/L) | −0.495 | −7.21 | 5.963 |
| Hematocrit (ratio) | −0.206 | −5.04 | 4.996 |
| Red cell count (109/L) | −0.128 | −4.87 | 4.641 |
| Mean cell volume (fl) | −0.136 | −5.73 | 5.546 |
| Mean cell Hb (pg) | −0.344 | −5.36 | 4.608 |
| Mean cell Hb concentration (g/L) | 0.050 | −6.94 | 7.375 |
| White cell count (109/L) | −0.489 | −6.04 | 5.255 |
| Neutrophil count (109/L) | 0.031 | −5.80 | 6.003 |
| Lymphocytes (109/L) | −0.030 | −5.64 | 5.422 |
| Monocyte count (109/L) | 0.112 | −5.93 | 5.751 |
| Basophil count (109/L) | −0.640 | −5.88 | 4.626 |
| Eosinophil count (109/L) | 0.691 | −10.8 | 12.99 |
| Platelet count (109/L) | 17.76 | −25.5 | 59.05 |
| Random glucose (micromole/L) | −0.536 | −6.45 | 4.911 |
| Urea (mmol/L) | 0.533 | −5.08 | 6.125 |
| Sodium (mmol/L) | −0.203 | −5.25 | 5.327 |
| Potassium (mmol/L) | 0.144 | −4.96 | 5.791 |
| Chloride (mmol/L) | −1.05 | −7.05 | 4.631 |
| Magnesium (mmol/L) | −0.090 | −5.95 | 6.038 |
| Bicarbonate (mmol/L) | 0.856 | −4.65 | 6.472 |
| Creatinine (micromole/L) | −1.77 | −8.39 | 4.721 |
| Total protein (g/L) | −0.896 | −6.93 | 5.036 |
| Albumin (g/L) | −1.05 | −6.37 | 4.081 |
| AST (U/L) | −10.3 | −28.4 | 7.814 |
| Total bilirubin (micromole/L) | 0.741 | −4.83 | 6.798 |
| GGT (U/L) | −15.2 | −44.2 | 15.82 |
| ALT (U/L) | −2.97 | −26.2 | 20.77 |
| Alkaline phosphatase (U/L) | −1.37 | −9.75 | 6.990 |
| LDH (U/L) | −18.8 | −62.7 | 25.53 |
| Ferritin (micromole/L) | 63.66 | −96.9 | 220.1 |
| CRP (mg/L) | 0.168 | −27.1 | 27.82 |
| Troponin (ng/L) | −0.469 | −10.5 | 10.06 |
| Triglycerides (mmol/L) | −0.696 | −6.69 | 4.959 |
| D-dimer (ng/ml) | 5.609 | −208 | 209.1 |
| Creatinine kinase (U/L) | −23.1 | −76.8 | 25.12 |
| INR (ratio) | −0.444 | −5.43 | 4.268 |
| Prothrombin time (seconds) | −0.484 | −5.42 | 4.740 |
| Fibrinogen (g/L) | −0.071 | −6.14 | 5.822 |
| aPTT (seconds) | 0.226 | −6.06 | 6.674 |
| Protein C (IU/ml) | −0.134 | −5.78 | 5.671 |
| Antithrombin (IU/ml) | −0.131 | −6.16 | 5.718 |
| O2 saturation (%) | 0.616 | −3.49 | 4.848 |
| Respiratory rate (bpm) | 0.774 | −5.06 | 6.715 |
| Systolic blood pressure (mm Hg) | −3.62 | −13.6 | 6.819 |
| Diastolic blood pressure (mm Hg) | −0.773 | −7.81 | 6.425 |
| Temperature (degrees C) | 0.196 | −4.78 | 5.035 |
| Pulse (bpm) | 5.242 | −4.52 | 14.52 |
| ECG rate | 2.143 | −8.11 | 12.86 |
| ECG Q̇tc | −4.37 | −22.5 | 13.09 |
Definition of abbreviations: ALT = alanine aminotransferase; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; CRP = C-reactive protein; GGT = γ-glutamyltransferase; Hb = hemoglobin; HPD = highest posterior density; INR = international normalized ratio; LDH = lactate dehydrogenase; Q̇tc = corrected Q̇t interval.
All of the 95% HPD-credible intervals include zero, and therefore none are statistically significant.