Philippe Camus, M.D.

Dijon, France

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Gefitinib

See PMID 20016372. The huge majority of cases emanate from Asia

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

I - Interstitial/parenchymal lung disease

I.a

Pneumonitis (ILD)
I.b

Pneumonitis (ILD), acute and/or severe (may cause ARDS)
I.g

Pulmonary fibrosis
I.m

Diffuse alveolar damage (DAD) (see alsoo under IIb and XVf)

II - Pulmonary edema - Acute lung injury - ARDS

II.e

ARDS - Acute lung injury

III - Pulmonary/alveolar./airway hemorrhage/bleeding

III.a

Alveolar hemorrhage (AH), diffuse AH (DAH)

VI - Pleural and/or pericardial involvement

VI.f

Pneumothorax
VI.ac

Pneumothorax, bilateral

XI - Miscellaneous

XI.t

Cavitation/necrosis of lung tumor or metastases

XII - Cardiovascular involvement / toxicity

XII.d

Myocarditis (can be fulminant)
XII.az

Necrotizing myocarditis (w/o evidence for CAD)

XVI - Imaging

XVI.b

Imaging: Ground-glass opacities (GGO) / shadowing
XVI.ad

Imaging: Lung cysts or bullae (see also XVI ah/bf)

XVIII - Cytological, biochemical features of/in BAL, pleural fluid or FNA

XVIII.a

BAL: An excess proportion of lymphocytes
XVIII.c

BAL: An excess proportion of eosinophils

XIX - Pathology

XIX.o

Path: Diffuse alveolar damage (DAD-pattern) (see also IL)
XIX.w

Path: Pulmonary fibrosis (UIP-pattern)
XIX.cq

Path: Necrotizing myocarditis