ID
43472
Description
ODM derived from http://clinicaltrials.gov/show/NCT00822393
Link
http://clinicaltrials.gov/show/NCT00822393
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/16/14 4/16/14 - Julian Varghese
- 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 DRKS00006115 NCT00822393 Acute Myeloid Leukemia
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Patients with acute promyelocytic leukaemia with t(15,17)(q22,q12) and in CR1
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0023487
- SNOMED CT 2011_0131
- 110004001
- MedDRA 14.1
- 10001019
- ICD-10-CM Version 2010
- C92.4
- UMLS CUI 2011AA
- C1515724
- UMLS CUI 2011AA
- C0205435
- SNOMED CT 2011_0131
- 255216001
- UMLS CUI 2011AA
- C0544452
- SNOMED CT 2011_0131
- 277022003
Description
Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1444657
- SNOMED CT 2011_0131
- 410536001
- UMLS CUI 2011AA
- C2242529
- MedDRA 14.1
- 10067862
- UMLS CUI 2011AA
- CL420107
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0243087
Description
patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C1565489
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
- UMLS CUI 2011AA
- C0011946
- SNOMED CT 2011_0131
- 108241001
- MedDRA 14.1
- 10061105
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0022671
- SNOMED CT 2011_0131
- 70536003
- MedDRA 14.1
- 10038533
- ICD-9-CM Version 2011
- 55.6
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
- UMLS CUI 2011AA
- C1519815
- UMLS CUI 2011AA
- C0444686
- SNOMED CT 2011_0131
- 258090004
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Description
patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0024115
- SNOMED CT 2011_0131
- 19829001
- MedDRA 14.1
- 10025082
- ICD-10-CM Version 2010
- J98.4
- UMLS CUI 2011AA
- C1516251
- UMLS CUI 2011AA
- CL414841
- UMLS CUI 2011AA
- C0743330
- SNOMED CT 2011_0131
- 161941007
- MedDRA 14.1
- 10013969
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0919655
- MedDRA 14.1
- 10050322
Description
patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0018799
- SNOMED CT 2011_0131
- 56265001
- MedDRA 14.1
- 10061024
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C0013516
- SNOMED CT 2011_0131
- 40701008
- MedDRA 14.1
- 10014116
- ICD-9-CM Version 2011
- 88.72
- UMLS CUI 2011AA
- C0428772
- SNOMED CT 2011_0131
- 250908004
- MedDRA 14.1
- 10069170
Description
patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0948807
- MedDRA 14.1
- 10052254
- UMLS CUI 2011AA
- C1444656
- SNOMED CT 2011_0131
- 410535002
- UMLS CUI 2011AA
- C0020433
- SNOMED CT 2011_0131
- 14783006
- MedDRA 14.1
- 10020578
- UMLS CUI 2011AA
- C1519815
- 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
Description
Active malignant involvement of the CNS
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- CL364385
- UMLS CUI 2011AA
- C1314939
- SNOMED CT 2011_0131
- 248448006
- UMLS CUI 2011AA
- C1269563
- SNOMED CT 2011_0131
- 278199004
Description
HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
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
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 40733004
- MedDRA 14.1
- 10021881
- LOINC Version 232
- MTHU034915
- ICD-9-CM Version 2011
- 136.9
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0547047
- SNOMED CT 2011_0131
- 260370003
- UMLS CUI 2011AA
- C0006560
- SNOMED CT 2011_0131
- 61425002
- LOINC Version 232
- MTHU002335
- UMLS CUI 2011AA
- C0072027
- SNOMED CT 2011_0131
- 418752001
- LOINC Version 232
- MTHU015794
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0042721
- SNOMED CT 2011_0131
- 3738000
- MedDRA 14.1
- 10019799
- LOINC Version 232
- MTHU020837
- ICD-10-CM Version 2010
- B19
- ICD-9-CM Version 2011
- 070
- CTCAE 1105E
- E11410
Description
Previous allogeneic HSCT
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C2242529
- MedDRA 14.1
- 10067862
Description
Pleural effusion or ascites > 1.0 L
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0032227
- SNOMED CT 2011_0131
- 60046008
- MedDRA 14.1
- 10035598
- ICD-10-CM Version 2010
- J90
- ICD-9-CM Version 2011
- 511.9
- CTCAE 1105E
- E13486
- UMLS CUI 2011AA
- C0003962
- SNOMED CT 2011_0131
- 389026000
- MedDRA 14.1
- 10003445
- ICD-10-CM Version 2010
- R18
- ICD-9-CM Version 2011
- 789.5
- CTCAE 1105E
- E10502
Description
Pregnancy or lactation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0032961
- SNOMED CT 2011_0131
- 289908002
- MedDRA 14.1
- 10036556
- LOINC Version 232
- MTHU035048
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
Known hypersensitivity to treosulfan, busulfan and/or related ingredients
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0076959
- SNOMED CT 2011_0131
- 395912000
- UMLS CUI 2011AA
- C0700015
- SNOMED CT 2011_0131
- 387138002
- LOINC Version 232
- MTHU004760
- UMLS CUI 2011AA
- C0699792
- SNOMED CT 2011_0131
- 263498003
- UMLS CUI 2011AA
- CL414967
Description
Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol
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
- C0013230
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Non-cooperative behaviour or non-compliance
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0424350
- SNOMED CT 2011_0131
- 248042003
- UMLS CUI 2011AA
- C0457432
- SNOMED CT 2011_0131
- 258143003
Description
Psychiatric diseases or conditions that might compromise the ability to give informed consent
Data type
boolean
Alias
- 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
- UMLS CUI 2011AA
- C0809986
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0184704
- SNOMED CT 2011_0131
- 55149002
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
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104102000 (SNOMED CT 2011_0131)
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MTHU016536 (LOINC Version 232)
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128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
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238.75 (ICD-9-CM Version 2011)
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C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
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MTHU021331 (LOINC Version 232)
C0332282 (UMLS CUI 2011AA)
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77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
234336002 (SNOMED CT 2011_0131)
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C1315037 (UMLS CUI 2011AA)
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20323000 (SNOMED CT 2011_0131)
C0037047 (UMLS CUI 2011AA)
375005 (SNOMED CT 2011_0131)
MTHU016169 (LOINC Version 232)
SIB (HL7 V3 2006_05)
CL414920 (UMLS CUI 2011AA)
CL414700 (UMLS CUI 2011AA)
CL414920 (UMLS CUI 2011AA)
C1449559 (UMLS CUI 2011AA)
C0555911 (UMLS CUI 2011AA)
260075000 (SNOMED CT 2011_0131)
C0555916 (UMLS CUI 2011AA)
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49495002 (SNOMED CT 2011_0131)
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C0019737 (UMLS CUI 2011AA)
54481006 (SNOMED CT 2011_0131)
MTHU027937 (LOINC Version 232)
C0019751 (UMLS CUI 2011AA)
80188006 (SNOMED CT 2011_0131)
MTHU033946 (LOINC Version 232)
C1514873 (UMLS CUI 2011AA)
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246173007 (SNOMED CT 2011_0131)
C0019627 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
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146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
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CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
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268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C1515724 (UMLS CUI 2011AA)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
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10067862 (MedDRA 14.1)
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C0205082 (UMLS CUI 2011AA)
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24484000 (SNOMED CT 2011_0131)
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108241001 (SNOMED CT 2011_0131)
10061105 (MedDRA 14.1)
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288556008 (SNOMED CT 2011_0131)
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10038533 (MedDRA 14.1)
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10040230 (MedDRA 14.1)
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C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
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167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
24484000 (SNOMED CT 2011_0131)
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19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
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10050322 (MedDRA 14.1)
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10020578 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
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56935002 (SNOMED CT 2011_0131)
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CL364385 (UMLS CUI 2011AA)
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248448006 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (SNOMED CT 2011_0131)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
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40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
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C0547047 (UMLS CUI 2011AA)
260370003 (SNOMED CT 2011_0131)
C0006560 (UMLS CUI 2011AA)
61425002 (SNOMED CT 2011_0131)
MTHU002335 (LOINC Version 232)
C0072027 (UMLS CUI 2011AA)
418752001 (SNOMED CT 2011_0131)
MTHU015794 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0042721 (UMLS CUI 2011AA)
3738000 (SNOMED CT 2011_0131)
10019799 (MedDRA 14.1)
MTHU020837 (LOINC Version 232)
B19 (ICD-10-CM Version 2010)
070 (ICD-9-CM Version 2011)
E11410 (CTCAE 1105E)
9130008 (SNOMED CT 2011_0131)
C2242529 (UMLS CUI 2011AA)
10067862 (MedDRA 14.1)
60046008 (SNOMED CT 2011_0131)
10035598 (MedDRA 14.1)
J90 (ICD-10-CM Version 2010)
511.9 (ICD-9-CM Version 2011)
E13486 (CTCAE 1105E)
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
418634005 (SNOMED CT 2011_0131)
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C0076959 (UMLS CUI 2011AA)
395912000 (SNOMED CT 2011_0131)
C0700015 (UMLS CUI 2011AA)
387138002 (SNOMED CT 2011_0131)
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C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
CL414967 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
248042003 (SNOMED CT 2011_0131)
C0457432 (UMLS CUI 2011AA)
258143003 (SNOMED CT 2011_0131)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0809986 (UMLS CUI 2011AA)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)