Table 1.
Suggested Toxicity Grading Scale for the Dengue Human Infection Modela
| Local Reaction to Injectable Product | Mild (Grade 1) | Moderate (Grade 2) | Severe (Grade 3) | Potentially Life-Threatening (Grade 4) |
|---|---|---|---|---|
| Pain | Does not interfere with activity | Repeated use of nonnarcotic pain reliever for >24 h or interferes with activity | Any use of narcotic pain reliever or prevents daily activity | ER visit or hospitalization |
| Tenderness | Mild discomfort to touch | Discomfort with movement | Significant discomfort at rest | ER visit or hospitalization |
| Erythema/redness | 2.5–5 cm | 5.1–10 cm | >10 cm | Necrosis or exfoliative dermatitis |
| Induration/swelling | 2.5–5 cm and does not interfere with activity | 5.1–10 cm or interferes with activity | >10 cm or prevents daily activity | Necrosis |
| Fever, °C | 38.0–38.4 | 38.5–38.9 | 39.0–40 | >40 |
| Tachycardia (beats per min) | 101–115 | 106–1306 | >130 | ER visit or hospitalization for arrhythmia |
| Bradycardia (beats per min) | 50–54 | 45–49 | <45 | ER visit or hospitalization for arrhythmia |
| Hypertension (systolic), mm Hg | 141–150 | 151–155 | >155 | ER visit or hospitalization for malignant hypertension |
| Hypertension (diastolic), mm Hg | 91–95 | 96–100 | >100 | ER visit or hospitalization for malignant hypertension |
| Hypotension (systolic), mm Hg | 85–89 | 80–84 | <80 | ER visit or hospitalization for hypotensive shock |
| Respiratory rate (breaths per min | 17–20 | 21–25 | > 25 | Intubation |
| Nausea/vomiting | No interference with activity or 1–2 episodes per 24 h | Some interference with activity or >2 episodes per 24 h | Prevents daily activity, requires outpatient IV hydration | ER visit or hospitalization for hypotensive shock |
| Diarrhea | 2–3 loose stools or <400 g per 24 h | 4–5 loose stools or 400–800 g per 24 h | 6 or more watery stools or >800 g per 24 h or requires outpatient IV hydration | ER visit or hospitalization |
| Headache | No interference with activity | Repeated use of nonnarcotic pain reliever >24 h or some interference with activity | Significant; any use of narcotic pain reliever or prevents daily activity | ER visit or hospitalization |
| Fatigue | No interference with activity | Some interference with activity | Significant; prevents daily activity | ER visit or hospitalization |
| Myalgia | No interference with activity | Some interference with activity | Significant; prevents daily activity | ER visit or hospitalization |
Abbreviations: ER, emergency room; IV, intravenous.
a Derived from the Food and Drug Administration toxicity grading scale for clinical trials [11].