Adverse event grading criteria for safety bloods
| Grade 1 (Mild) | Grade 2 (Moderate) | Grade 3 (Severe) | Grade 4 (Emergency) | |
|---|---|---|---|---|
| Haematology | ||||
| Haemoglobin change from baseline (g/dL) | <1.5 | 1.5–2.0 | 2.1–5.0 | >5 |
| Total white cell count (×109/L): elevated | 10.8–15.0 | 15.1–20.0 | 20.1–25.0 | >25.0 |
| Total white cell count (×109/L): depressed | 2.5–3.5 | 1.5–2.4 | 1.0–1.4 | <1.0 |
| Neutrophil count (×109/L) | 1.5–2.0 | 1.0–1.4 | 0.5–0.9 | <0.5 |
| Platelet count (×109/L) | 125–140 | 100–124 | 25–99 | <25 |
| Biochemistry | ||||
| Sodium (mmol/L): hyponatraemia | 132–134 | 130–131 | 125–129 | <125 |
| Sodium (mmol/L): hypernatraemia | 144–145 | 146–147 | 148–150 | >150 |
| Potassium (mmol/L): hypokalaemia | 3.5–3.6 | 3.3–3.4 | 3.1–3.2 | <3.1 |
| Potassium (mmol/L): hyperkalaemia | 5.1–5.2 | 5.3–5.4 | 5.5–5.6 | >5.6 |
| Urea (mmol/L) | 8.2–8.9 | 9.0–11 | >11 | RRT |
| Creatinine (µmol/L) | 132–150 | 151–176 | 177–221 | >221 or RRT |
| ALT or AST (IU/L) | 1.1–2.5×ULN | 2.6–5.0×ULN | 5.1–10×ULN | >10×ULN |
| Bilirubin (µmol/L): with increased ALT/AST | 1.1–1.25×ULN | 1.26–1.5×ULN | 1.51–1.75×ULN | >1.75×ULN |
| Bilirubin (µmol/L): with normal ALT/AST | 1.1–1.5×ULN | 1.6–2.0×ULN | 2.0–3.0×ULN | >3.0×ULN |
| Alkaline phosphatase (IU/L) | 1.1–2.0×ULN | 2.1–3.0×ULN | 3.1–10×ULN | >10×ULN |
| Amylase (IU/L) | 1.1–1.5×ULN | 1.6–2.0×ULN | 2.1–5.0×ULN | >5.0×ULN |
| Albumin (g/L): hypoalbuminaemia | 28–31 | 25–27 | <25 | NA |
| C reactive protein (mg/L) | 11–30 | 31–100 | 101–200 | >200 |
ALT, alanine transaminase; AST, aspartate transaminase; NA, not applicable; RRT, renal replacement therapy; ULN, upper limit of normal.