ID
44159
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00478777
Link
http://clinicaltrials.gov/show/NCT00478777
Trefwoorden
Versies (4)
- 11-12-13 11-12-13 - Martin Dugas
- 14-04-14 14-04-14 - Julian Varghese
- 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
- 20-09-21 20-09-21 -
Geüploaded op
20 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
The presence of any of the following will exclude a subject from study enrollment:
Datatype
boolean
Alias
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C1516879
Beschrijving
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Datatype
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
Beschrijving
Pregnant or lactating females.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- CL414917
Beschrijving
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.
Datatype
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
Beschrijving
Any of the following laboratory abnormalities:
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
Beschrijving
Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Beschrijving
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Beschrijving
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- UMLS CUI 2011AA
- C0032112
Beschrijving
Serum creatinine >2.5 mg/dL (221 µmol/L)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beschrijving
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Datatype
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
Beschrijving
Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Beschrijving
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.
Datatype
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
Beschrijving
Prior history of stroke and/or thromboembolic event
Datatype
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
Beschrijving
Known hypersensitivity to thalidomide or dexamethasone.
Datatype
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
Beschrijving
Prior history of uncontrollable side effects to dexamethasone therapy.
Datatype
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
Beschrijving
The development of a desquamating rash while taking thalidomide.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1559142
- CTCAE 1105E
- MTHU117394
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
Beschrijving
Neuropathy >= Grade 2.
Datatype
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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10028997 (MedDRA 14.1)
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109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
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