ID
44595
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01019174
Link
http://clinicaltrials.gov/show/NCT01019174
Palabras clave
Versiones (3)
- 7/12/13 7/12/13 - Martin Dugas
- 17/4/14 17/4/14 - Julian Varghese
- 27/9/21 27/9/21 -
Subido en
27 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01019174 Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject 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
- C2700409
- UMLS CUI 2011AA
- C2348583
Descripción
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0086287
- SNOMED CT 2011_0131
- 248152002
- HL7 V3 2006_05
- F
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0032992
- SNOMED CT 2011_0131
- 169565003
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Descripción
Any condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from 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
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0681873
Descripción
Patient currently is enrolled in another clinical research study or has been enrolled in such a study within 4 weeks before randomization/registration and/or is receiving an investigational agent for any reason or has received such an agent within 4 weeks before randomization/registration.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1516879
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0013230
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0034656
Descripción
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
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
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
- UMLS CUI 2011AA
- C0010583
- SNOMED CT 2011_0131
- 387420009
- LOINC Version 232
- MTHU029970
Descripción
Any prior use of lenalidomide.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1144149
- SNOMED CT 2011_0131
- 421471009
Descripción
Concurrent use of other anti-cancer agents or treatments.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205420
- SNOMED CT 2011_0131
- 68405009
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0003392
- SNOMED CT 2011_0131
- 372688009
- UMLS CUI 2011AA
- C0920425
Descripción
Known positive for HIV or infectious hepatitis, type 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
- 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
Descripción
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0444956
- SNOMED CT 2011_0131
- 261829003
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Descripción
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0021083
Descripción
Major surgery within 4 weeks before randomization/registration.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0679637
Descripción
Myocardial infarction within 6 months before randomization/registration, New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Tipo de datos
boolean
Alias
- 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
- C1319795
- SNOMED CT 2011_0131
- 420913000
- MedDRA 14.1
- 10064081
- UMLS CUI 2011AA
- C1319796
- SNOMED CT 2011_0131
- 422293003
- MedDRA 14.1
- 10064082
- UMLS CUI 2011AA
- C0018801
- SNOMED CT 2011_0131
- 155374007
- MedDRA 14.1
- 10019279
- ICD-9-CM Version 2011
- 428
- CTCAE 1105E
- E10124
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- 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
- C0085612
- SNOMED CT 2011_0131
- 44103008
- MedDRA 14.1
- 10047281
- ICD-10-CM Version 2010
- I49.01
- CTCAE 1105E
- E10230
- UMLS CUI 2011AA
- C1623258
- SNOMED CT 2011_0131
- 46825001
- MedDRA 14.1
- 10014084
- UMLS CUI 2011AA
- C0022116
- SNOMED CT 2011_0131
- 52674009
- MedDRA 14.1
- 10061255
- UMLS CUI 2011AA
- C0018796
- SNOMED CT 2011_0131
- 24964005
- UMLS CUI 2011AA
- C1704258
Descripción
Cardiac amyloidosis.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0268407
- SNOMED CT 2011_0131
- 16573007
- MedDRA 14.1
- 10007509
Descripción
Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1868885
- MedDRA 14.1
- 10066860
- UMLS CUI 2011AA
- C0860161
- MedDRA 14.1
- 10012619
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0221423
- SNOMED CT 2011_0131
- 39104002
- MedDRA 14.1
- 10040658
- ICD-10-CM Version 2010
- R69
- 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
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C1554962
- HL7 V3 2006_05
- C
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Descripción
Any systemic infection requiring treatment.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0243026
- SNOMED CT 2011_0131
- 91302008
- MedDRA 14.1
- 10040047
- ICD-9-CM Version 2011
- 995.91
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0039798
Descripción
Cystitis.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0010692
- SNOMED CT 2011_0131
- 38822007
- MedDRA 14.1
- 10011781
- ICD-10-CM Version 2010
- N30
- ICD-9-CM Version 2011
- 595.9
- CTCAE 1105E
- E11309
Descripción
Disturbance of urinary flow.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2699787
- UMLS CUI 2011AA
- C0012797
- SNOMED CT 2011_0131
- 60309003
- MedDRA 14.1
- 10013523
Descripción
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
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
- C1512806
- UMLS CUI 2011AA
- C0019134
- SNOMED CT 2011_0131
- 372877000
- LOINC Version 232
- MTHU003766
- UMLS CUI 2011AA
- C0019139
- SNOMED CT 2011_0131
- 87233003
- LOINC Version 232
- MTHU014939
- UMLS CUI 2011AA
- C0721444
- UMLS CUI 2011AA
- C0445202
- SNOMED CT 2011_0131
- 262073000
- MedDRA 14.1
- 10036893
- UMLS CUI 2011AA
- C0003281
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10036572 (MedDRA 14.1)
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10010808 (MedDRA 14.1)
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C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
CL415200 (UMLS CUI 2011AA)
C0445107 (UMLS CUI 2011AA)
262009000 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (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)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0019139 (UMLS CUI 2011AA)
87233003 (SNOMED CT 2011_0131)
MTHU014939 (LOINC Version 232)
C0721444 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C0003281 (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)
C2700409 (UMLS CUI 2011AA)
C2348583 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0681873 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
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)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0003392 (UMLS CUI 2011AA)
372688009 (SNOMED CT 2011_0131)
C0920425 (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)
74964007 (SNOMED CT 2011_0131)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
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)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0205318 (UMLS CUI 2011AA)
19032002 (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)
C0085612 (UMLS CUI 2011AA)
44103008 (SNOMED CT 2011_0131)
10047281 (MedDRA 14.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE 1105E)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0022116 (UMLS CUI 2011AA)
52674009 (SNOMED CT 2011_0131)
10061255 (MedDRA 14.1)
C0018796 (UMLS CUI 2011AA)
24964005 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
10066860 (MedDRA 14.1)
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
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)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
38822007 (SNOMED CT 2011_0131)
10011781 (MedDRA 14.1)
N30 (ICD-10-CM Version 2010)
595.9 (ICD-9-CM Version 2011)
E11309 (CTCAE 1105E)
C0012797 (UMLS CUI 2011AA)
60309003 (SNOMED CT 2011_0131)
10013523 (MedDRA 14.1)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
C0019139 (UMLS CUI 2011AA)
87233003 (SNOMED CT 2011_0131)
MTHU014939 (LOINC Version 232)
C0721444 (UMLS CUI 2011AA)
C0445202 (UMLS CUI 2011AA)
262073000 (SNOMED CT 2011_0131)
10036893 (MedDRA 14.1)
C0003281 (UMLS CUI 2011AA)