| Adverse event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Allergy/immunology | |||||
| Allergic reaction/hypersensitivity | Transient flushing or rash; drug fever <38°C (<100.4°F) | Rash; flushing; urticaria; dyspnoea; drug fever ⩾38°C (⩾100.4°F) | Symptomatic bronchospasm, with or without urticaria; parenteral medication(s) indicated; allergy-related oedema/angioedema; hypotension | Anaphylaxis | Death |
| Cardiac arrhythmia | |||||
| Supraventricular arrhythmia | Asymptomatic, intervention not indicated | Non-urgent medical intervention indicated | Symptomatic and incompletely controlled medically, or controlled with device (eg, pacemaker) | Life-threatening (eg, arrhythmia associated with CHF, hypotension, syncope, shock) | Death |
| Vasovagal episode | – | Present without LOC | Present with LOC | Life-threatening consequences | Death |
| Ventricular arrhythmia | Asymptomatic, no intervention indicated | Non-urgent medical intervention indicated | Symptomatic and incompletely controlled medically or controlled with device (eg, defibrillator) | Life-threatening (eg, arrhythmia associated with CHF, hypotension, syncope, shock) | Death |
| Cardiac general | |||||
| Cardiac troponin I | – | – | Levels consistent with unstable angina as defined by the manufacturer | Levels consistent with myocardial infarction as defined by the manufacturer | Death |
| Hypertension | Asymptomatic, transient (<24 h) increase by >20 mmHg (diastolic) or to >150/100 if previously within normal limits; intervention not indicated | Recurrent or persistent (⩾24 h) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 if previously within normal limits; monotherapy may be indicated | Requiring more than one drug or more intensive therapy than previously | Life-threatening consequences (eg, hypertensive crisis) | Death |
| Constitutional symptoms | |||||
| Fatigue | Mild fatigue over baseline | Moderate or causing difficulty performing some ADL | Severe fatigue interfering with ADL | Disabling | – |
| Gastrointestinal | |||||
| Dry mouth/salivary gland (xerostomia) | Symptomatic (dry or thick saliva) without significant dietary alteration; unstimulated saliva flow >0.2 ml/min | Symptomatic and significant oral intake alteration (eg, copious water, other lubricants, diet limited to purees and/or soft, moist foods); unstimulated saliva 0.1–0.2 ml/min | Symptoms leading to inability adequately to aliment orally; IV fluids, tube feedings, or TPN indicated; unstimulated saliva <0.1 ml/min | – | – |
| Neurology | |||||
| Confusion | Transient confusion, disorientation, or attention deficit | Confusion, disorientation, or attention deficit interfering with function, but not interfering with ADL | Confusion or delirium interfering with ADL | Harmful to others or self; hospitalisation indicated | Death |
| Dizziness | With head movements or nystagmus only; not interfering with function | Interfering with function, but not interfering with ADL | Interfering with ADL | Disabling | – |
| Memory impairment | Memory impairment not interfering with function | Memory impairment interfering with function, but not interfering with ADL | Memory impairment interfering with ADL | Amnesia | – |
| Tremor | Mild and brief or intermittent but not interfering with function | Moderate tremor interfering with function, but not interfering with ADL | Severe tremor interfering with ADL | Disabling | – |
| Pain | |||||
| Pain | Mild pain not interfering with function | Moderate pain; pain or analgesics interfering with function, but not interfering with ADL | Severe pain; pain or analgesics severely interfering with ADL | Disabling | – |
| Pulmonary/upper respiratory | |||||
| Dyspnoea | Dyspnoea on exertion, but can walk 1 flight of stairs without stopping | Dyspnoea on exertion but unable to walk 1 flight of stairs or 1 city block (0.1 km) without stopping | Dyspnoea with ADL | Dyspnoea at rest; intubation/ventilator indicated | Death |
| Renal/genitourinary | |||||
| Urinary retention | Hesitancy or dribbling, no significant residual urine; retention occurring during the immediate postoperative period | Hesitancy requiring medication; or operative bladder atony requiring indwelling catheter beyond immediate postoperative period but for <6 weeks | More than daily catheterisation indicated; urological intervention indicated (eg, TURP, suprapubic tube, urethrotomy) | Life-threatening consequences; organ failure (eg, bladder rupture); operative intervention requiring organ resection indicated | Death |
ADL, activities of daily living; CHF, congestive heart failure; IV, intravenous; LOC, loss of consciousness; TPN, total parenteral nutrition; TURP, transurethral resection of prostate.