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If ⩾2 responders were observed among the initial 10 evaluable patients in any dosing cohort, an additional 19 patients would be accrued into the second stage of study.
Rescue doses of a short-acting form of the same opioid subtype as the maintenance opioid can be used in any dosing frequency.
If ⩾6 responses were observed in any dosing cohort, ADI-PEG 20 would be considered effective; otherwise, it would be concluded that ADI-PEG 20 was not effective enough for further exploration in advanced HCC.
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A positive result is a statistically significant dose response and/or statistically significant increase in any dose group compared to concurrent negative controls using an appropriate statistical model.
There was no statistically significant increase in the frequencies of MNPCEs among 2,000 PCEs in any dose level of PHEA-C16-iron oxide.
No maximally tolerated dose (MTD) was reached since the highest dose failed to result in any dose limiting toxicities.
'Most frequent' is defined as ≥5% in any dose group or overall.
No patient experienced AE that led to discontinuation of the study medication in any dose cohort.
No DLTs occurred in any dose-escalation cohort or the safety expansion cohort.
No grade 3/4 anaemia or thrombocytopenia occurred in any dose levels.
Compared with controls, there were no significant differences in kidney weights in any dose group (Table 2).
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CEO of Professional Science Editing for Scientists @ prosciediting.com