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

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

 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)

 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