ID

43095

Description

ODM derived from http://clinicaltrials.gov/show/NCT01404741

Link

http://clinicaltrials.gov/show/NCT01404741

Keywords

Versions (3)
  1. 4/17/13 4/17/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01404741 Myelodysplastic Syndrome

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 55 Years to 70 Years
Description

age 55 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts <= 30 % (= RAEB-t according to FAB)
Description

Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts <= 30 % (= RAEB-t according to FAB)

Data type

boolean

Alias
UMLS CUI 2011AA
C0280451
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1292780
SNOMED CT 2011_0131
128838005
UMLS CUI 2011AA
C1515568
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0023480
SNOMED CT 2011_0131
127225006
MedDRA 14.1
10009018
ICD-10-CM Version 2010
C93.1
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
CL421536
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C2003903
UMLS CUI 2011AA
C2827405
UMLS CUI 2011AA
C0280449
UMLS CUI 2011AA
C0280028
SNOMED CT 2011_0131
110000005
MedDRA 14.1
10054593
ICD-10-CM Version 2010
C92.0
Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza)
Description

Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza)

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0806909
SNOMED CT 2011_0131
398303009
LOINC Version 232
MTHU008917
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0004475
SNOMED CT 2011_0131
412329008
Understand and voluntarily sign an informed consent form
Description

Understand and voluntarily sign an informed consent form

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
ECOG performance status finding <= 2
Description

ECOG performance status of <= 2 at study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of normal
Description

Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
UMLS CUI 2011AA
C0011221
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
UMLS CUI 2011AA
C1519815
Sufficient cardiac function (ejection fraction > 30 %)
Description

Sufficient cardiac function (ejection fraction > 30 %)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205410
SNOMED CT 2011_0131
51117008
UMLS CUI 2011AA
C0232164
SNOMED CT 2011_0131
86185002
UMLS CUI 2011AA
C0232174
SNOMED CT 2011_0131
70822001
Exclusion Criteria
Description

Exclusion Criteria

Blasts > 30 % in bone marrow at time of diagnosis
Description

Blasts > 30 % in bone marrow at time of diagnosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0368761
SNOMED CT 2011_0131
312256009
LOINC Version 232
MTHU005201
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
CL343029
HL7 V3 2006_05
%
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
Central nervous system (CNS) involvement status
Description

Central nervous involvement

Data type

boolean

Alias
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
260766009
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Description

Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0860433
MedDRA 14.1
10022997
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
Total bilirubin, SGPT or SGOT >= 3 times upper the normal level
Description

Total bilirubin, SGPT or SGOT >= 3 times upper the normal level

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
LVEF - Left ventricular ejection fraction
Description

Left ventricular ejection fraction < 30 %

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
Creatinine clearance (CrCl) measurement
Description

Creatinine clearance < 30 ml/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
DLCO < 35 % and/or receiving supplementary continuous oxygen
Description

DLCO < 35 % and/or receiving supplementary continuous oxygen

Data type

boolean

Alias
UMLS CUI 2011AA
C1516251
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0919655
MedDRA 14.1
10050322
Pregnant or breastfeeding female subject
Description

Pregnant or breastfeeding female subject

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0681850
Patients with a life-expectancy of < six months because of another debilitating disease
Description

Patients with a life-expectancy of < six months because of another debilitating disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0004093
SNOMED CT 2011_0131
260407003
MedDRA 14.1
10011942
ICD-10-CM Version 2010
R53.1
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Serious psychiatric or psychological disorders
Description

Serious psychiatric or psychological disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Uncontrolled invasive fungal infection at time of registration
Description

Uncontrolled invasive fungal infection at time of registration

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
Known positive for HIV or acute infectious hepatitis, type A, B or C
Description

Known positive for HIV or acute infectious hepatitis, type A, B or C

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0019159
SNOMED CT 2011_0131
40468003
MedDRA 14.1
10019780
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
Description

Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0023636
UMLS CUI 2011AA
C0013230
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 55 Years to 70 Years
Item
age 55 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts <= 30 % (= RAEB-t according to FAB)
Item
Patients with proven de novo or therapy-related MDS / CMML (WBC <13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts <= 30 % (= RAEB-t according to FAB)
boolean
C0280451 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1292780 (UMLS CUI 2011AA)
128838005 (SNOMED CT 2011_0131)
C1515568 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0023480 (UMLS CUI 2011AA)
127225006 (SNOMED CT 2011_0131)
10009018 (MedDRA 14.1)
C93.1 (ICD-10-CM Version 2010)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
CL421536 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2003903 (UMLS CUI 2011AA)
C2827405 (UMLS CUI 2011AA)
C0280449 (UMLS CUI 2011AA)
C0280028 (UMLS CUI 2011AA)
110000005 (SNOMED CT 2011_0131)
10054593 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza)
Item
Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza)
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
MTHU008917 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0004475 (UMLS CUI 2011AA)
412329008 (SNOMED CT 2011_0131)
Understand and voluntarily sign an informed consent form
Item
Understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
ECOG performance status of <= 2 at study entry
Item
ECOG performance status finding <= 2
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of normal
Item
Adequate renal and liver function: creatinine and bilirubin < 3 x the upper limit of normal
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Sufficient cardiac function (ejection fraction > 30 %)
Item
Sufficient cardiac function (ejection fraction > 30 %)
boolean
C0205410 (UMLS CUI 2011AA)
51117008 (SNOMED CT 2011_0131)
C0232164 (UMLS CUI 2011AA)
86185002 (SNOMED CT 2011_0131)
C0232174 (UMLS CUI 2011AA)
70822001 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Blasts > 30 % in bone marrow at time of diagnosis
Item
Blasts > 30 % in bone marrow at time of diagnosis
boolean
C0368761 (UMLS CUI 2011AA)
312256009 (SNOMED CT 2011_0131)
MTHU005201 (LOINC Version 232)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
CL343029 (UMLS CUI 2011AA)
% (HL7 V3 2006_05)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
Central nervous involvement
Item
Central nervous system (CNS) involvement status
boolean
C0007682 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Item
Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0860433 (UMLS CUI 2011AA)
10022997 (MedDRA 14.1)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
Total bilirubin, SGPT or SGOT >= 3 times upper the normal level
Item
Total bilirubin, SGPT or SGOT >= 3 times upper the normal level
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Left ventricular ejection fraction < 30 %
Item
LVEF - Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
Creatinine clearance < 30 ml/min
Item
Creatinine clearance (CrCl) measurement
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
DLCO < 35 % and/or receiving supplementary continuous oxygen
Item
DLCO < 35 % and/or receiving supplementary continuous oxygen
boolean
C1516251 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
Pregnant or breastfeeding female subject
Item
Pregnant or breastfeeding female subject
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
Patients with a life-expectancy of < six months because of another debilitating disease
Item
Patients with a life-expectancy of < six months because of another debilitating disease
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0004093 (UMLS CUI 2011AA)
260407003 (SNOMED CT 2011_0131)
10011942 (MedDRA 14.1)
R53.1 (ICD-10-CM Version 2010)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Serious psychiatric or psychological disorders
Item
Serious psychiatric or psychological disorders
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
Uncontrolled invasive fungal infection at time of registration
Item
Uncontrolled invasive fungal infection at time of registration
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
Known positive for HIV or acute infectious hepatitis, type A, B or C
Item
Known positive for HIV or acute infectious hepatitis, type A, B or C
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0019159 (UMLS CUI 2011AA)
40468003 (SNOMED CT 2011_0131)
10019780 (MedDRA 14.1)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
Item
Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study
boolean
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)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0023636 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
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