Philippe Camus, M.D.

Dijon, France

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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

XLVI.b

Pulmonary arterial hypertension

Preliminary information to be published indicates a plausible relationship between exposure to dasatinib and the development of PHTn

Publications

Hickey PM, Thompson AA, Charalampopoulos A, Elliot CA, Hamilton N, Kiely DG, Lawrie A, Sabroe I, Condliffe R

Bosutinib therapy resulting in severe deterioration of pre-existing pulmonary arterial hypertension.

The European respiratory journal 2016 11;48;1514-1516 — 2016 11 — 1514-1516