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Dose levels were Arm A: level −1 AUC 5 carboplatin, level −2 remove from study; Arm B: dose level −1 decitabine 45 mg m−2, level −2 carboplatin AUC 5, level −3 stop decitabine and continue carboplatin alone.
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Table 2 Patient Clavien Dindo distribution Grade Number of patients I II 119 III IV 356 V 2 (removed from study).
However, after four months, one nodule began to grow, and he was removed from study (Figure 3).
Ten mice in each group (cancer bearing and saline vehicle-inoculated control groups) were bled by cardiac puncture at each time point and removed from study.
Ten animals each from tumor-bearing and control groups were bled and removed from study at each time point; serum S100A6 level was quantified by ECLISA for all study mice.
Four patients were removed from study because of toxicity.
Two were removed from study because of toxicity.
Patients removed from study for symptomatic progression during the DLT window were replaced.
These patients could then be removed from study, or be treated with a higher dose.
Half of Tp53 Δ11/+ were removed from study by 1 year of age because of tumor formation.
If platelets continued <100,000/mm at 2 weeks, patients were removed from study.
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