Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure-QTc in patients with advanced or refractory solid tumors.

Elodie ValadeAnne-Gaëlle DosneHong XieRobert B KleimanLilian Y LiJuan Jose Perez RuixoDaniele Ouellet

Published in: Cancer chemotherapy and pharmacology (2019)

ECG data and the concentration-QTc relationships demonstrate that erdafitinib does not prolong QTc interval and has no effects on cardiac repolarization or other ECG parameters. Clinical trial registration numbers NCT01703481, EudraCT: 2012-000697-34.

Keyphrases

clinical trial
left ventricular
heart rate variability
heart rate
electronic health record
big data
study protocol
open label
randomized controlled trial
phase ii
heart failure
blood pressure
phase iii
artificial intelligence
data analysis