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The Drug-Induced Cardiotoxicity Website and App

Frequency - Incidence

Incidence of cardiac 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 cardiac 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

XIV.a

Pleural effusion (uni- or bilateral) (can accompany DI-LDs)

Publications

Hann CL, Burns TF, Dowlati A, Morgensztern D, Ward PJ, Koch MM, Chen C, Ludwig C, Patel M, Nimeiri H, Komarnitsky P, Camidge DR

A Phase 1 Study Evaluating Rovalpituzumab Tesirine in Frontline Treatment of Patients With Extensive-Stage SCLC.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2021;16(9):1582-1588

Johnson ML, Zvirbule Z, Laktionov K, Helland A, Cho BC, Gutierrez V, Colinet B, Lena H, Wolf M, Gottfried M, Okamoto I, van der Leest C, Rich P, Hung JY, Appenzeller C, Sun Z, Maag D, Luo Y, Nickner C, Vajikova A, Komarnitsky P, Bar J

Rovalpituzumab Tesirine as a Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage-SCLC: Results From the Phase 3 MERU Study.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2021;16(9):1570-1581

Malhotra J, Nikolinakos P, Leal T, Lehman J, Morgensztern D, Patel JD, Wrangle JM, Curigliano G, Greillier L, Johnson ML, Ready N, Robinet G, Lally S, Maag D, Valenzuela R, Blot V, Besse B

A Phase 1-2 Study of Rovalpituzumab Tesirine in Combination With Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Extensive-Stage SCLC.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2021;16(9):1559-1569

Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP

Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study.

Clinical cancer research : an official journal of the American Association for Cancer Research. 2019;25(23):6958-6966

Udagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I

Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer.

Lung cancer (Amsterdam, Netherlands). 2019;135:145-150

Rudin CM, Pietanza MC, Bauer TM, Ready N, Morgensztern D, Glisson BS, Byers LA, Johnson ML, Burris HA 3rd, Robert F, Han TH, Bheddah S, Theiss N, Watson S, Mathur D, Vennapusa B, Zayed H, Lally S, Strickland DK, Govindan R, Dylla SJ, Peng SL, Spigel DR, S

Rovalpituzumab tesirine, a DLL3-targeted antibody-drug conjugate, in recurrent small-cell lung cancer: a first-in-human, first-in-class, open-label, phase 1 study.

The Lancet. Oncology. 2017;18(1):42-51