Philippe Camus, M.D.

Dijon, France

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Erlotinib

Most of the signal in the literature emanates from Japan (e.g. PMID 22610257). Reviews at PMID 20016372, 24332320. Recurrence may not lead to relapse (PMID 25550194), thus challenging causality

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

II - Pulmonary edema - Acute lung injury - ARDS

III - Pulmonary/alveolar./airway hemorrhage/bleeding

V - Pleural and/or pericardial involvement

XI - Miscellaneous

XII - Cardiovascular involvement / toxicity

XV - Pathology

XVI - Imaging

XXI - Rechallenge data