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Published byWerner Morgenstern Modified over 6 years ago
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EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial Steffen T. Simon, MD, MSc, Marianne Kloke, MD, Bernd Alt-Epping, MD, Jan Gärtner, MD, Martin Hellmich, Dr rer med, Dipl Math oec, Rebecca Hein, Dr sc hum, Dipl Math oec, Maren Piel, Oliver A. Cornely, MD, FACP, FIDSA, Friedemann Nauck, MD, Raymond Voltz, MD Journal of Pain and Symptom Management Volume 52, Issue 5, Pages (November 2016) DOI: /j.jpainsymman Copyright © Terms and Conditions
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Fig. 1 Titration phase for FBT and IRM. The initial dose of IRM was one-sixth of the patient's daily oral morphine equivalent dose (DOME) based on recommendation in the literature.17 ED = episodic dyspnea; EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; TPh = titration phase. Journal of Pain and Symptom Management , DOI: ( /j.jpainsymman ) Copyright © Terms and Conditions
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Fig. 2 Trial flowchart. AE = adverse event; EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; R = randomization; SAE = serious adverse event; TPh = titration phase; V = visit. Journal of Pain and Symptom Management , DOI: ( /j.jpainsymman ) Copyright © Terms and Conditions
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Fig. 3 Flow diagram. EPh = efficacy phase; FBT = fentanyl buccal tablet; IRM = immediate-release morphine; ITT = intention-to-treat; TPh = titration phase. Journal of Pain and Symptom Management , DOI: ( /j.jpainsymman ) Copyright © Terms and Conditions
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Fig. 4 Breathlessness intensity of episodes (NRS 0–10) from 0 to 60 minutes after study drug administration. FBT = fentanyl buccal tablet; IRM = immediate-release morphine; NRS = Numeric Rating Scale 0–10. Journal of Pain and Symptom Management , DOI: ( /j.jpainsymman ) Copyright © Terms and Conditions
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