ID
5127
Description
ODM derived from http://clinicaltrials.gov/show/NCT01311687
Lien
http://clinicaltrials.gov/show/NCT01311687
Mots-clés
Versions (3)
- 21/03/2013 21/03/2013 - Martin Dugas
- 19/04/2014 19/04/2014 - Julian Varghese
- 20/09/2021 20/09/2021 -
Téléchargé le
19 avril 2014
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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Eligibility NCT01311687 Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Description
Any of the following laboratory abnormalities:
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0332282
- SNOMED CT 2011_0131
- 255260001
- UMLS CUI 2011AA
- C0438215
- SNOMED CT 2011_0131
- 165346000
- MedDRA 14.1
- 10023547
Description
Absolute neutrophil count (ANC) < 1,000/microL
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Description
Platelet count < 75,000/microL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1287267
Description
Creatinine Clearance < 45 mL/min
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0373595
- SNOMED CT 2011_0131
- 167181009
- MedDRA 14.1
- 10011371
Description
Corrected serum calcium > 14 mg/dL
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0455288
- SNOMED CT 2011_0131
- 166708003
Description
Hemoglobin <= 8 g/dL
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0518015
- SNOMED CT 2011_0131
- 38082009
- MedDRA 14.1
- 10019481
- LOINC Version 232
- LP14449-0
Description
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)
Type de données
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
Description
Serum total bilirubin > 2.0 mg/dL
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Description
Previous therapy with Pomalidomide
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C2347624
Description
Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
Type de données
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
Description
Resistance to high-dose dexamethasone used in the last line of therapy
Type de données
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
Description
Peripheral neuropathy >= Grade 2
Type de données
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
Description
Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C0149615
Description
Subjects who are planning for or who are eligible for stem cell transplant
Type de données
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
Description
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
Type de données
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
Description
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
Type de données
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
Description
Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
Type de données
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0013230
Description
Subjects with conditions requiring chronic steroid or immunosuppressive treatment
Type de données
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
Description
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Type de données
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
Description
Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
Type de données
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
Description
Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
Type de données
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
Description
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
Type de données
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
Description
Pregnant or breastfeeding females
Type de données
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
Description
Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
Type de données
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
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
397934002 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
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276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
410525008 (SNOMED CT 2011_0131)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0002073 (UMLS CUI 2011AA)
372669002 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0023115 (UMLS CUI 2011AA)
400664008 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0870186 (UMLS CUI 2011AA)
C2756969 (UMLS CUI 2011AA)
6993007 (SNOMED CT 2011_0131)
MTHU001953 (LOINC Version 232)
C0680854 (UMLS CUI 2011AA)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C2347624 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
10052033 (MedDRA 14.1)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
166708003 (SNOMED CT 2011_0131)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
C2347624 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
397943006 (SNOMED CT 2011_0131)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
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)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0205169 (UMLS CUI 2011AA)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0002962 (UMLS CUI 2011AA)
194828000 (SNOMED CT 2011_0131)
10002383 (MedDRA 14.1)
I20 (ICD-10-CM Version 2010)
413 (ICD-9-CM Version 2011)
C0002963 (UMLS CUI 2011AA)
87343002 (SNOMED CT 2011_0131)
10036759 (MedDRA 14.1)
I20.1 (ICD-10-CM Version 2010)
413.1 (ICD-9-CM Version 2011)
C0032134 (UMLS CUI 2011AA)
20720000 (SNOMED CT 2011_0131)
10035486 (MedDRA 14.1)
99.71 (ICD-9-CM Version 2011)
C0679637 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C1515926 (UMLS CUI 2011AA)
C0000854 (UMLS CUI 2011AA)
C2347624 (UMLS CUI 2011AA)
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)
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)