age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient following allogeneic SCT
Item
Patient following allogeneic SCT
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
Item
Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
boolean
C0439615 (UMLS CUI 2011AA)
255217005 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032520 (UMLS CUI 2011AA)
258066000 (SNOMED CT 2011_0131)
10050967 (MedDRA 14.1)
C0369083 (UMLS CUI 2011AA)
121109001 (SNOMED CT 2011_0131)
MTHU011613 (LOINC Version 232)
C0005768 (UMLS CUI 2011AA)
C0082181 (UMLS CUI 2011AA)
C1510438 (UMLS CUI 2011AA)
272392009 (SNOMED CT 2011_0131)
Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization
Item
Absolute neutrophil count (ANC) >=1000 cells/microL on 2 consecutive follow-ups within 10 days before randomization
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
Item
Patient has a creatinine clearance of >=25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
boolean
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C1272745 (UMLS CUI 2011AA)
385633008 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
Item
None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
boolean
C0549184 (UMLS CUI 2011AA)
260413007 (SNOMED CT 2011_0131)
C0521362 (UMLS CUI 2011AA)
MTHU031867 (LOINC Version 232)
C0018133 (UMLS CUI 2011AA)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
Patient has a suspected or diagnosed CMV disease
Item
Patient has a suspected or diagnosed CMV disease
boolean
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
Patient has received syngeneic SCT
Item
Patient has received syngeneic SCT
boolean
C1514756 (UMLS CUI 2011AA)
C2985487 (UMLS CUI 2011AA)
Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
Item
Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
boolean
C1514756 (UMLS CUI 2011AA)
C1517586 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patient with a body weight <50 kg or >95 kg,
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
Item
Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
boolean
C1514756 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0001367 (UMLS CUI 2011AA)
372729009 (SNOMED CT 2011_0131)
MTHU006764 (LOINC Version 232)
C0249458 (UMLS CUI 2011AA)
96098007 (SNOMED CT 2011_0131)
C0209227 (UMLS CUI 2011AA)
387557001 (SNOMED CT 2011_0131)
Patient who has participated in this study before,
Item
Patient who has participated in this study before,
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
Item
Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
boolean
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
C1883713 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
The ANC is <1000 cells/microL on 2 consecutive follow-ups, or
Item
The ANC is <1000 cells/microL on 2 consecutive follow-ups, or
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions
Item
A platelet count of >=25000/microL can not be achieved/maintained with platelet transfusions
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0086818 (UMLS CUI 2011AA)
12719002 (SNOMED CT 2011_0131)
10035543 (MedDRA 14.1)
99.05 (ICD-9-CM Version 2011)
C1272276 (UMLS CUI 2011AA)
390801001 (SNOMED CT 2011_0131)
A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions
Item
A hemoglobin level of >=8g/dL can not be achieved/maintained by red blood cell transfusions
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C0086252 (UMLS CUI 2011AA)
116863004 (SNOMED CT 2011_0131)
C1272276 (UMLS CUI 2011AA)
390801001 (SNOMED CT 2011_0131)