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This is also supported by the fact that mortality was not affected in the older RCTs, which one would have expected when more patients develop ARDS [16, 29, 30].
More patients develop AKI outside the ICU and present with it rather than developing AKI while in ICU.
The recommended dose of sunitinib will be dose level 1 (25 mg) if not more than 0/3 or 1/6 patients develop DLT AND 2 or more patients develop DLT in dose level 2. No recommended dose will be defined if two or more patients develop DLT in dose level 1.
If DLT occurs in one patient additional three patients will be treated at DL 2. If 2 or more patients develop DLT, DL 1 will be the recommended dose for the phase II part of the study the study.
The recommended dose of sunitinib will be dose level 1 (25 mg) if not more than 0/3 or 1/6 patients develop DLT AND 2 or more patients develop DLT in dose level 2. No recommended dose will be defined if two or more patients develop DLT in dose level 1. Secondary end points are pathological and imaging response to the treatment and postoperative morbidity of tumour resection.
Dose escalation is halted if two ore more patients develop DLT. 3 Patients are treated with combined RCHT (RT with GD 60 Gy, ED 2.0 Gy + TMZ 75 mg/m/day, 6 weeks) Cetuximab (ERBITUX®) 400 mg/m2 in week 1, thereafter at a dose of 250 mg/m2 weekly during RCHT.
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During the ICU stay, ten more patients developed sepsis: two trauma patients (5.4%), one neurologic patient (4.8%), two respiratory patients (18.2%) and five other patients (26.3%).
Twenty-four more patients developed organ dysfunction during their ICU stay (18 cases of multiple organ failure and 6 cases of uncontrolled systemic sepsis).
Compared to patients treated with ZDV/3TC/LPV/r, more patients developed high total and LDL cholesterol levels according to NCEP criteria.
However, more patients developed grade 2-3 diarrhea.
In the low-activity group, more patients developed poorly differentiated and hormone receptor-negative tumours.
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