ID

44159

Description

ODM derived from http://clinicaltrials.gov/show/NCT00478777

Link

http://clinicaltrials.gov/show/NCT00478777

Keywords

Versions (4)
  1. 12/11/13 12/11/13 - Martin Dugas
  2. 4/14/14 4/14/14 - Julian Varghese
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003823 NCT00478777 Relapsed or Refractory Multiple Myeloma

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18
Description

age at least 18

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Must understand and voluntarily sign an informed consent form.
Description

Must understand and voluntarily sign an informed consent form.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Must be >=18 years of age at the time of signing the informed consent form.
Description

Must be >=18 years of age at the time of signing the informed consent form.

Data type

boolean

Alias
UMLS CUI 2011AA
C0700597
SNOMED CT 2011_0131
41847000
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0009797
Must be able to adhere to the study visit schedule and other protocol requirements.
Description

Must be able to adhere to the study visit schedule and other protocol requirements.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1709747
Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
Description

Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
C0039798
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1335499
Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
Description

Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0039736
SNOMED CT 2011_0131
78702007
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0009429
Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).
Description

Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).

Data type

boolean

Alias
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
CL428482
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0599938
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1442488
Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).
Description

Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).

Data type

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0030490
SNOMED CT 2011_0131
49010003
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
CL423120
ECOG performance status <= 2
Description

Eastern Cooperative Oncology Group (ECOG) performance status score <=2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug 2) while participating in the study and 3) for at least 28 days after discontinuation from the study.
Description

Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug 2) while participating in the study and 3) for at least 28 days after discontinuation from the study.

Data type

boolean

Alias
UMLS CUI 2011AA
CL414917
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL068143
UMLS CUI 2011AA
C0009253
SNOMED CT 2011_0131
258139002
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
The presence of any of the following will exclude a subject from study enrollment:
Description

The presence of any of the following will exclude a subject from study enrollment:

Data type

boolean

Alias
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1516879
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Description

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

Data type

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
Pregnant or lactating females.
Description

Pregnant or lactating females.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
CL414917
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.
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 or confounds the ability to interpret data from the study.

Data type

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
Any of the following laboratory abnormalities:
Description

Any of the following laboratory abnormalities:

Data type

boolean

Alias
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1704258
Absolute Neutrophil Count
Description

Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Description

Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
UMLS CUI 2011AA
C0032112
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Description

Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
UMLS CUI 2011AA
C0032112
Serum Creatinine Measurement
Description

Serum creatinine >2.5 mg/dL (221 µmol/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Description

Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

Data type

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
Serum Total Bilirubin Measurement
Description

Serum total bilirubin >2.0 mg/dL (34 µmol/L)

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
313840000
MedDRA 14.1
10040162
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.
Description

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.

Data type

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
Prior history of stroke and/or thromboembolic event
Description

Prior history of stroke and/or thromboembolic event

Data type

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
Known hypersensitivity to thalidomide or dexamethasone.
Description

Known hypersensitivity to thalidomide or dexamethasone.

Data type

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
Prior history of uncontrollable side effects to dexamethasone therapy.
Description

Prior history of uncontrollable side effects to dexamethasone therapy.

Data type

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
The development of a desquamating rash while taking thalidomide.
Description

The development of a desquamating rash while taking thalidomide.

Data type

boolean

Alias
UMLS CUI 2011AA
C1559142
CTCAE 1105E
MTHU117394
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0039736
SNOMED CT 2011_0131
78702007
Neuropathy >= Grade 2.
Description

Neuropathy >= Grade 2.

Data type

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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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18
Item
age at least 18
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Must understand and voluntarily sign an informed consent form.
Item
Must understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI 2011AA)
Must be >=18 years of age at the time of signing the informed consent form.
Item
Must be >=18 years of age at the time of signing the informed consent form.
boolean
C0700597 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0009797 (UMLS CUI 2011AA)
Must be able to adhere to the study visit schedule and other protocol requirements.
Item
Must be able to adhere to the study visit schedule and other protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
Item
Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
C0039798 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
Item
Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C0009429 (UMLS CUI 2011AA)
Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).
Item
Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to or at baseline (Day 1).
boolean
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0599938 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).
Item
Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g excreted in a 24-hour collection sample).
boolean
C1513040 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
C0030490 (UMLS CUI 2011AA)
49010003 (SNOMED CT 2011_0131)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
Eastern Cooperative Oncology Group (ECOG) performance status score <=2
Item
ECOG performance status <= 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug 2) while participating in the study and 3) for at least 28 days after discontinuation from the study.
Item
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug 2) while participating in the study and 3) for at least 28 days after discontinuation from the study.
boolean
CL414917 (UMLS CUI 2011AA)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL068143 (UMLS CUI 2011AA)
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
The presence of any of the following will exclude a subject from study enrollment:
Item
The presence of any of the following will exclude a subject from study enrollment:
boolean
CL411789 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Item
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
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)
Pregnant or lactating females.
Item
Pregnant or lactating females.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
CL414917 (UMLS CUI 2011AA)
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.
Item
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.
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1281905 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681873 (UMLS CUI 2011AA)
Any of the following laboratory abnormalities:
Item
Any of the following laboratory abnormalities:
boolean
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Item
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
boolean
C1287267 (UMLS CUI 2011AA)
C0032112 (UMLS CUI 2011AA)
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Item
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
boolean
C1287267 (UMLS CUI 2011AA)
C0032112 (UMLS CUI 2011AA)
Serum creatinine >2.5 mg/dL (221 µmol/L)
Item
Serum Creatinine Measurement
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Item
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
boolean
C0201899 (UMLS CUI 2011AA)
45896001 (SNOMED CT 2011_0131)
10003476 (MedDRA 14.1)
C0201836 (UMLS CUI 2011AA)
34608000 (SNOMED CT 2011_0131)
10001546 (MedDRA 14.1)
C0376147 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Item
Serum Total Bilirubin Measurement
boolean
C1278039 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
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.
Item
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.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (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)
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)
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)
C0242793 (UMLS CUI 2011AA)
Prior history of stroke and/or thromboembolic event
Item
Prior history of stroke and/or thromboembolic event
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0040038 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
Known hypersensitivity to thalidomide or dexamethasone.
Item
Known hypersensitivity to thalidomide or dexamethasone.
boolean
C0020517 (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)
Prior history of uncontrollable side effects to dexamethasone therapy.
Item
Prior history of uncontrollable side effects to dexamethasone therapy.
boolean
C0262926 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL330043 (UMLS CUI 2011AA)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
The development of a desquamating rash while taking thalidomide.
Item
The development of a desquamating rash while taking thalidomide.
boolean
C1559142 (UMLS CUI 2011AA)
MTHU117394 (CTCAE 1105E)
C1512806 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
Neuropathy >= Grade 2.
Item
Neuropathy >= Grade 2.
boolean
C0442874 (UMLS CUI 2011AA)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
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