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The study design included an eltrombopag dose escalation phase starting at 75 mg daily to determine the optimal biological dose (OBD).
After randomization children started with treatment for 20 days (dose escalation phase) followed by a maintenance phase of two years.
In the dose escalation phase of the study, PEG-Dox was raised in steps of 5 mg/m2 in a 3-by-3 design, starting with 5 mgroup(group 1) up to 20 mgroup(group 4).
Patients were enrolled on a dose escalation phase (DEP) initially, followed by a cohort expansion phase (CEP).
A two center, dose escalation phase I study of rViscumin was carried out.
This was an open-label, dose escalation phase I trial.
The initial dose escalation phase of the study consisted of four cohorts.
All these patients had grade 2/3 hyperglycemia, as noted in the dose escalation phase.
In order to be exposed to steady-state concentrations of pazopanib and to determine the effects of ifosfamide administration on pazopanib pharmacokinetics (PK), patients in the dose-escalation phase started on pazopanib 7 days prior to the first cycle of ifosfamide.
Berthon, C. et al. Bromodomain inhibitor OTX015 in patients with acute leukaemia: a dose-escalation, phase 1 study.
Testing preload dependence may also be helpful in the de-escalation phase of shock management.
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