ID
44159
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00478777
Link
http://clinicaltrials.gov/show/NCT00478777
Palabras clave
Versiones (4)
- 11/12/13 11/12/13 - Martin Dugas
- 14/4/14 14/4/14 - Julian Varghese
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Descripción
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
The presence of any of the following will exclude a subject from study enrollment:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C1516879
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
- 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
Descripción
Pregnant or lactating females.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- CL414917
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 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
- C1281905
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C1273101
- SNOMED CT 2011_0131
- 395659009
- UMLS CUI 2011AA
- C0681873
Descripción
Any of the following laboratory abnormalities:
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
Descripción
Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Descripción
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Descripción
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Descripción
Serum creatinine >2.5 mg/dL (221 µmol/L)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Descripción
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Tipo de datos
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
Descripción
Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Descripción
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.
Tipo de datos
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
Descripción
Prior history of stroke and/or thromboembolic event
Tipo de datos
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
Descripción
Known hypersensitivity to thalidomide 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
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Descripción
Prior history of uncontrollable side effects to dexamethasone therapy.
Tipo de datos
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
Descripción
The development of a desquamating rash while taking thalidomide.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1559142
- CTCAE 1105E
- MTHU117394
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
Descripción
Neuropathy >= Grade 2.
Tipo de datos
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
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10040230 (MedDRA 14.1)
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313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
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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)
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