Questions	Criteria
	Overall			Stat.
	1	2	3
Was the study designed for dose-finding?	x	x	x	x
Was the objective to find a MTD?	x	x	x	x
Was the MTD clearly defined?	x	x	x	x
Was the objective to find a DLT?
Did the objective include a Pharmaco-kinetics analysis?
Was the study mono or multi-centric?
If it was multi-centric, was the study national or international?
Was the experimental treatment a combination of several therapeutic agents or only one?
Was the dose allocation method described?	x	x	x	x
If yes, was it justified?		x	x	x
Was the starting dose specified?	x	x	x	x
If yes, was it justified?		x
Was the number of dose-levels mentioned?		x	x	x
Were dose levels determined from preliminary animal or human studies?
Was the dose levels specification method given?
If yes, was it justified?
Was a prior dose-toxicity relationship described before the trial?
Was a non-decreasing dose-response relationship assumed?
Did the determination of dose meet ethical considerations?	x	x	x	x
Was the outcome assessor blinded?
Was the patient blinded?
Was the DLT precisely defined?
If yes, was it based on international grading systems such as OMS or NCI scales?	x	x	x
Was only the toxicity supposed related to the drug used to define the DLT?
Was the MTD defined?	x	x	x	x
Was the sample size fixed at the beginning of the trial?
Was the sample size justified?
If yes, was it adequate?
Was the initial fixed sample size reached?
If no, was any justification given?
Was the period of enrollment mentioned?
Did the study include patients with different diseases?
Was the patient population specified through the inclusion/exclusion criteria?	x	x	x	x
Was the MTD determined?	x	x	x	x
Was the probability of toxicity associated with the MTD given?
Was a precision given for the estimated MTD?
Were patients exposed to too low or too high dose?
Did the dose allocation along the trial match the described method?				x
Did the dose levels match the specification method?
Was the frequency of adverse effects acceptable?
Was treatment Pharmaco-kinetics profile estimated?
Was the efficacy evaluated?
Did efficacy modelization take into account for the dose allocation procedure?
Was there any statistical modeling of toxicity?
Were some patients withdrawn from the analysis?				x
Did the analysis include an intention-to-treat analysis?
Was the mortality reported?	x		x
If yes, was it related with the drug?	x