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DLT of this regimen is leukopenia, although toxicity is manageable at the recommended dose level.
We conclude that the recommended dose level of BR14 is between 1 mL and 4 mL; at this dosage, lesion detection is comparable to that of CE MRI.
Results at this recommended dose level showed no cumulative toxicities.
If there was again a DLT, the level below was the recommended dose level.
A total of 37 cycles have been applied to 17 patients at the recommended dose level.
It has only been observed in 24% of the patients treated at the recommended dose level in our study.
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In this regard, audits of the radiation dose in CT are important because they can provide valuable feedback about the amount of ionising radiation delivered to patients undergoing routine clinical CT examinations and allow gauging any difference between recommended dose levels and real practice.
It was noteworthy that the same dose of tivantinib was recommended for both EM and PM among Japanese patients with HCC, although the recommended dose levels of this agent differ for patients with other solid tumors.
TMZ and PCB, when combined at the recommended dose levels, are a reasonably effective and well-tolerated combination in treating patients with relapsed gliomas and tumour activity is seen in low-grade gliomas, AA, and GBM.
This favourable profile leads us to recommend dose level 2.A (sirolimus 5 mg per 24 h plus gemcitabine 800 mg m−2) as the optimal dose due to its well-proved safety record.
After the termination of the trial, the FDA added a summary of the results to the Epogen label, but it didn't limit the recommended dosing levels, which the agency had recently expanded.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com