Ursino, MorenoMorenoUrsinoYuan, YingYingYuanAlberti, CorinneCorinneAlbertiComets, EmmanuelleEmmanuelleCometsFavrais, GeraldineGeraldineFavraisFriede, TimTimFriedeLentz, FrederikeFrederikeLentzStallard, NigelNigelStallardZohar, SarahSarahZohar2019-07-092019-07-092018https://resolver.sub.uni-goettingen.de/purl?gro-2/59766Clinical trials in vulnerable populations are extremely difficult to conduct. A sequential phase I–II trial aimed at finding the appropriate dose of levetiracetam for treating neonatal seizures was planned with a maximum sample size of 50 newborns. Three primary outcomes are considered: efficacy and two types of toxicity that occur at the same time but are measured at different time points. In the case of failure, physicians could add a second agent as a rescue medication.The primary outcomeswere modelled via a logistic model for efficacy and aweighted likelihood with pseudo-outcomes for the two toxicities taking into account the dependences under Bayesian inference. Simulations were conducted to assess the design properties.enCC BY-NC 4.0https://creativecommons.org/licenses/by-nc/4.0610journal_article10.1111/rssc.12289https://resolver.sub.uni-goettingen.de/purl?gs-1/15931