ID
5127
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01311687
Link
http://clinicaltrials.gov/show/NCT01311687
Palabras clave
Versiones (3)
- 21/3/13 21/3/13 - Martin Dugas
- 19/4/14 19/4/14 - Julian Varghese
- 20/9/21 20/9/21 -
Subido en
19 de abril de 2014
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01311687 Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Descripción
Any of the following laboratory abnormalities:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
Descripción
Absolute neutrophil count (ANC) < 1,000/microL
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Descripción
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1287267
Descripción
Creatinine Clearance < 45 mL/min
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Descripción
Corrected serum calcium > 14 mg/dL
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0455288
- SNOMED CT 2011_0131
- 166708003
Descripción
Hemoglobin <= 8 g/dL
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0518015
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
Descripción
Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or Transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0004002
- SNOMED CT 2011_0131
- 26091008
- LOINC Version 232
- MTHU004883
- UMLS CUI 2011AA
- C0001899
- SNOMED CT 2011_0131
- 56935002
- LOINC Version 232
- MTHU006766
- UMLS CUI 2011AA
- C1519815
Descripción
Serum total bilirubin > 2.0 mg/dL
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Descripción
Previous therapy with Pomalidomide
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C2347624
Descripción
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
Tipo de datos
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
- C1144149
- SNOMED CT 2011_0131
- 421471009
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Descripción
Resistance to high-dose dexamethasone used in the last line of therapy
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514892
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Descripción
Peripheral neuropathy >= Grade 2
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0031117
- MedDRA 14.1
- 10029331
- ICD-10-CM Version 2010
- G64
- ICD-9-CM Version 2011
- 350-359.99
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Descripción
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0149615
Descripción
Subjects who are planning for or who are eligible for stem cell transplant
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C1548635
- HL7 V3 2006_05
- ELG
- UMLS CUI 2011AA
- C1504389
- MedDRA 14.1
- 10063581
Descripción
Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0018802
- SNOMED CT 2011_0131
- 42343007
- MedDRA 14.1
- 10007559
- LOINC Version 232
- MTHU020787
- ICD-10-CM Version 2010
- I50.9
- ICD-9-CM Version 2011
- 428.0
- UMLS CUI 2011AA
- C0027051
- SNOMED CT 2011_0131
- 22298006
- MedDRA 14.1
- 10028596
- LOINC Version 232
- MTHU035551
- ICD-10-CM Version 2010
- I21-I22
- ICD-9-CM Version 2011
- 410
- CTCAE 1105E
- E10152
- UMLS CUI 2011AA
- C0002965
- SNOMED CT 2011_0131
- 4557003
- MedDRA 14.1
- 10002388
- ICD-10-CM Version 2010
- I20.0
- ICD-9-CM Version 2011
- 411.1
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0002962
- SNOMED CT 2011_0131
- 194828000
- MedDRA 14.1
- 10002383
- ICD-10-CM Version 2010
- I20
- ICD-9-CM Version 2011
- 413
- UMLS CUI 2011AA
- C0002963
- SNOMED CT 2011_0131
- 87343002
- MedDRA 14.1
- 10036759
- ICD-10-CM Version 2010
- I20.1
- ICD-9-CM Version 2011
- 413.1
Descripción
Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0032134
- SNOMED CT 2011_0131
- 20720000
- MedDRA 14.1
- 10035486
- ICD-9-CM Version 2011
- 99.71
- UMLS CUI 2011AA
- C0679637
- UMLS CUI 2011AA
- C0034619
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
Descripción
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
Descripción
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0149783
- SNOMED CT 2011_0131
- 297279009
- MedDRA 14.1
- 10062117
- UMLS CUI 2011AA
- C0021079
- SNOMED CT 2011_0131
- 86553008
Descripción
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- UMLS CUI 2011AA
- C0678227
- SNOMED CT 2011_0131
- 23981006
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C2348568
Descripción
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0021149
- UMLS CUI 2011AA
- C0017178
- SNOMED CT 2011_0131
- 119292006
- MedDRA 14.1
- 10017944
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C1515926
- UMLS CUI 2011AA
- C0000854
- UMLS CUI 2011AA
- C2347624
Descripción
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1299582
- SNOMED CT 2011_0131
- 371151008
- UMLS CUI 2011AA
- C0558080
- SNOMED CT 2011_0131
- 225465005
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0445202
- SNOMED CT 2011_0131
- 262073000
- MedDRA 14.1
- 10036893
- UMLS CUI 2011AA
- C1704311
- UMLS CUI 2011AA
- C0039798
Descripción
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
- 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
- C2348583
Descripción
Pregnant or breastfeeding females
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0015780
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
Descripción
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
Tipo de datos
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
- 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
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26091008 (SNOMED CT 2011_0131)
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56935002 (SNOMED CT 2011_0131)
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I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
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386134007 (SNOMED CT 2011_0131)
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371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C1704311 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
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)
C2348583 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019159 (UMLS CUI 2011AA)
40468003 (SNOMED CT 2011_0131)
10019780 (MedDRA 14.1)
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66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
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50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)