Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
Item
Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
boolean
C1709854 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0040739 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0441766 (UMLS CUI 2011AA)
258215001 (SNOMED CT 2011_0131)
MTHU035012 (LOINC Version 232)
C0441767 (UMLS CUI 2011AA)
258219007 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0441771 (UMLS CUI 2011AA)
258224005 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1514391 (UMLS CUI 2011AA)
C1709160 (UMLS CUI 2011AA)
C0037284 (UMLS CUI 2011AA)
95324001 (SNOMED CT 2011_0131)
10040882 (MedDRA 14.1)
Minimum period of 6 month after renal transplantation
Item
Minimum period of 6 month after renal transplantation
boolean
C1524031 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
Stable renal function and a calculated creatinine clearance of at least 40 ml/min
Item
Stable renal function and a calculated creatinine clearance of at least 40 ml/min
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Proteinuria <= 800 mg/d at time of enrolment
Item
Proteinuria <= 800 mg/d at time of enrolment
boolean
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
Item
Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
boolean
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0280100 (UMLS CUI 2011AA)
10065252 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Current Sirolimus- or Everolimus-intake
Item
Current Sirolimus- or Everolimus-intake
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0541315 (UMLS CUI 2011AA)
428698007 (SNOMED CT 2011_0131)
MTHU026817 (LOINC Version 232)
Instable graft function (creatinine clearance < 40 ml/min)
Item
Instable graft function (creatinine clearance < 40 ml/min)
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Graft rejection within the 3 previous months
Item
Graft rejection
boolean
C0018129 (UMLS CUI 2011AA)
72627004 (SNOMED CT 2011_0131)
10044439 (MedDRA 14.1)
Proteinuria > 800 mg/d
Item
Proteinuria
boolean
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
Item
Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0020473 (UMLS CUI 2011AA)
55822004 (SNOMED CT 2011_0131)
10062060 (MedDRA 14.1)
E78.5 (ICD-10-CM Version 2010)
C0008377 (UMLS CUI 2011AA)
84698008 (SNOMED CT 2011_0131)
MTHU003147 (LOINC Version 232)
C0041004 (UMLS CUI 2011AA)
85600001 (SNOMED CT 2011_0131)
MTHU003166 (LOINC Version 232)
Leucopenia < 2500/nl
Item
Leukocytopenia
boolean
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
Thrombocytopenia < 90/nl
Item
Thrombocytopenia
boolean
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)
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
Item
Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Known allergy to macrolides
Item
Known allergy to macrolides
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0282563 (UMLS CUI 2011AA)
428787002 (SNOMED CT 2011_0131)
Current participation in other studies
Item
Current participation in other studies
boolean
C2348568 (UMLS CUI 2011AA)
Refusal to sign informed consent form
Item
Refusal to sign informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
Neoplasm other than defined as inclusion criteria
Item
Neoplasm other than defined as inclusion criteria
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
CL425202 (UMLS CUI 2011AA)
All contraindications to SRL (see package insert, appendix)
Item
All contraindications to SRL (see package insert, appendix)
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
Persons who are detained officially or legally to an official institute
Item
Persons who are detained officially or legally to an official institute
boolean
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
C0680725 (UMLS CUI 2011AA)
C0442681 (UMLS CUI 2011AA)
257656006 (SNOMED CT 2011_0131)
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