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Table 2 Grading of key everolimus-related adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) [45]

From: Management of everolimus-associated adverse events in patients with tuberous sclerosis complex: a practical guide

Adverse event Grade 1 Grade 2 Grade 3 Grade 4
Non-infectious pneumonitis Asymptomatic Symptomatic; not interfering with ADL Severe symptoms; interfering with ADL, oxygen indicated Life-threatening respiratory comprise; urgent intervention indicated
Infections None Localised; local intervention indicated IV antibiotic, antifungal or antiviral intervention indicated; radiology/operative intervention indicated Life-threatening consequences, e.g. septic shock, hypotension, acidosis, necrosis
Stomatitis Minimal; normal diet Symptomatic, but can eat and swallow; modified diet Symptomatic; unable to adequately aliment or hydrate orally Symptoms associated with life-threatening consequences
Rash Macular or popular eruption or erythema without associated symptoms Macular or papular eruption or erythema with pruritus or other associated symptoms; localised desquamation or other lesions covering Severe, generalised erythroderma or macular, papular or vesicular eruption; desquamation covering ≥50% BSA Generalised exfoliative, ulcerative, or bullous dermatitis
Metabolic events
 Hypercholesterolaemia, >ULN–300 >300–400 >400–500 >500
 mg/dL (mmol/L) (>ULN–7.75) (>7.75–10.34) (>10.34–12.92) (>12.92)
 Hyperglycaemia, >ULN–160 >160–250 >250–500 >500
 mg/dL (mmol/L) (>ULN–8.9) (>8.9–13.9) (>13.9–27.8) (>27.8 or acidosis)
 Hypophosphataemia, <LLN–2.5 <2.5–2.0 <2.0–1.0 <1.0
 mg/dL (mmol/L) (<LLN–0.8) (<0.8–0.6) (<0.6–0.3) (<0.3)
 Hypertriglyceridaemia >ULN–2.5 × ULN >2.5–5.0 × ULN >5.0–10.0 × ULN >10.0 × ULN
  - - - -
 Hyperiuricaemia, mg/dL (mmol/L) >ULN–10 (≤0.59 without physiologic consequences) - >ULN–10 (≤0.59 without physiologic consequences) >10 (>0.59)
Myelosuppression, 109/L
 Platelets <LLN–75.0 <75.0–50.0 <50.0–25.0 <25.0
 Neutrophils <LLN–1.5 <1.5–1 <1.0–0.5 <0.5
  1. ADL activities of daily life, BSA body surface area, IV intravenous, LLN lower limit of normal, ULN upper limit of normal