Study Calendar Sample Clauses

Study Calendar. ‌ Enterostomy Screening Pre Treatment Phase Treatment Phase (Refeeding or Control) End of Treatment (Enterostomy Closure) Post Treatment Phase FU 1 3 months 3 months after Entero- stomy Closure) FU 2 6 months 6 months after Entero- stomy Closure) (FU 3 12 months)* 12 months after Entero- stomy Closure) at least 1 week up to 6 weeks at least 3 weeks up to 8 weeks approx. 6 weeks after Enterostomy Creation at least 2 weeks up to 8 weeks Data Assessment daily daily daily Outpatient clinic Outpatient clinic Outpatient clinic Randomization x Demographic data x Informed consent x In-/ Exclusion criteria x Operation protocol x Body weight x x X ** x x x Laboratory x *** X *** X *** x x x Refeeding protocol x Nutrition protocol x Medical history X Adverse events x x x x x x Time to first bowel movement after enterostomy closure [hours] x *only applicable for patients that are recruited early enough to complete the 12-month follow-up within the 48 month of overall study duration **weight is measured during the subsequent 5 days after reaching the primary endpoint ***every 2 weeks starting at randomization and in cases of pathologic clinical signs (jaundice, acholic stools)
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Study Calendar. Induction=4 cycles w/in # days of start One Cycle=21 Days Pre-Study Days 1& 3,Week 1 Day 1, Week 2 Day 1, Week 3 Off Study Follow- up LB-100, Atezolizumab, Carboplatin, Etoposide (Induction Cycles 1-4) X see section 5.1 LB-100, Atezolizumab, (Maintenance Cycle 5 and beyond) X see section 5.1 Informed consent X Demographics X Medical history X Concurrent meds 14 X Physical exam 14 X Day 1 only X X6 Vital sign, Weight 14 X Day 1 only X X6 Height X Performance Status 14 X Day 1 only X X6 CBC w/diff, plts 14 X Day 1 only X X X X6 Serum chemistry 14 X Day 1 only X X X X6 Urinalysis 14 X Day 1 only X X TSH, free T3, free T4 14 X Day 1 only EKG (triplicate) 8 14 X Cycles 1&2 only7 X8 X8 X Tumor measurements (RECIST)1,2 28 X Measurements repeated every 6-8 weeks (± 7 days)1 X5 Radiologic evaluation 28 X Should be performed every 6-8 weeks (± 7 days) X5 B-HCG 14 X PK Cycle3 1 Blood for correlatives X4 Cycles4 1, 4, 7 & 10 X4 Survival Follow-up X 1 Documentation (radiologic) must be provided for patients removed from study for progressive disease.

Related to Study Calendar

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