ID
44159
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00478777
Länk
http://clinicaltrials.gov/show/NCT00478777
Nyckelord
Versioner (4)
- 2013-12-11 2013-12-11 - Martin Dugas
- 2014-04-14 2014-04-14 - Julian Varghese
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
The presence of any of the following will exclude a subject from study enrollment:
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C1516879
Beskrivning
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
- 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
- C2700409
- UMLS CUI 2011AA
- C2348583
Beskrivning
Pregnant or lactating females.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- CL414917
Beskrivning
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1281905
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C1273101
- SNOMED CT 2011_0131
- 395659009
- UMLS CUI 2011AA
- C0681873
Beskrivning
Any of the following laboratory abnormalities:
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
Beskrivning
Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Beskrivning
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Beskrivning
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Beskrivning
Serum creatinine >2.5 mg/dL (221 µmol/L)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beskrivning
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0201899
- SNOMED CT 2011_0131
- 45896001
- MedDRA 14.1
- 10003476
- UMLS CUI 2011AA
- C0201836
- SNOMED CT 2011_0131
- 34608000
- MedDRA 14.1
- 10001546
- UMLS CUI 2011AA
- C0376147
- UMLS CUI 2011AA
- C1519815
Beskrivning
Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Beskrivning
Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >=1 year.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0026764
- SNOMED CT 2011_0131
- 109989006
- MedDRA 14.1
- 10028228
- ICD-10-CM Version 2010
- C90.0
- ICD-9-CM Version 2011
- 203.0
- UMLS CUI 2011AA
- C1554961
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0154084
- SNOMED CT 2011_0131
- 189336000
- MedDRA 14.1
- 10006189
- ICD-10-CM Version 2010
- D05
- ICD-9-CM Version 2011
- 233.0
- UMLS CUI 2011AA
- C0242793
Beskrivning
Prior history of stroke and/or thromboembolic event
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0040038
- MedDRA 14.1
- 10043565
Beskrivning
Known hypersensitivity to thalidomide or dexamethasone.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 418634005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Beskrivning
Prior history of uncontrollable side effects to dexamethasone therapy.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- CL330043
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Beskrivning
The development of a desquamating rash while taking thalidomide.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1559142
- CTCAE 1105E
- MTHU117394
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
Beskrivning
Neuropathy >= Grade 2.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0442874
- SNOMED CT 2011_0131
- 386033004
- MedDRA 14.1
- 10029328
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
41847000 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0009797 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C0009429 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0599938 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
C0030490 (UMLS CUI 2011AA)
49010003 (SNOMED CT 2011_0131)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL068143 (UMLS CUI 2011AA)
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
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)
C2700409 (UMLS CUI 2011AA)
C2348583 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
CL414917 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1281905 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681873 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0032112 (UMLS CUI 2011AA)
C0032112 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
45896001 (SNOMED CT 2011_0131)
10003476 (MedDRA 14.1)
C0201836 (UMLS CUI 2011AA)
34608000 (SNOMED CT 2011_0131)
10001546 (MedDRA 14.1)
C0376147 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C1554961 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154084 (UMLS CUI 2011AA)
189336000 (SNOMED CT 2011_0131)
10006189 (MedDRA 14.1)
D05 (ICD-10-CM Version 2010)
233.0 (ICD-9-CM Version 2011)
C0242793 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0040038 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL330043 (UMLS CUI 2011AA)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
MTHU117394 (CTCAE 1105E)
C1512806 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
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