English to Hungarian Medical Medical: Pharmaceuticals

Kontextus: protokoll szinopszis

"The first safety review of unblinded data by the iDMC will occur at approximately 6 months from the time of randomization of the first patient or when the safety run-in data are ready to be reviewed, whichever occurs first. For the safety run-in, unblinded safety data will be reviewed by the iDMC after the first 24 patients (approximately 12 patients per arm) have been enrolled and have completed at least two cycles of study treatment or withdrawn treatment."