ID

44595

Description

ODM derived from http://clinicaltrials.gov/show/NCT01019174

Link

http://clinicaltrials.gov/show/NCT01019174

Keywords

Versions (3)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01019174 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 Years
Description

age at least 18 Years

Data type

boolean

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

Understand and voluntarily sign an informed consent form.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Able to adhere to the study visit schedule and other protocol requirements.
Description

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
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C1709747
Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
Description

Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332132
SNOMED CT 2011_0131
48318009
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
C1514873
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1514815
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0065450
UMLS CUI 2011AA
C0741592
UMLS CUI 2011AA
C0225317
SNOMED CT 2011_0131
87784001
LOINC Version 232
MTHU016974
UMLS CUI 2011AA
C0032131
SNOMED CT 2011_0131
10639003
MedDRA 14.1
10035484
ICD-10-CM Version 2010
C90.3
UMLS CUI 2011AA
C0020437
SNOMED CT 2011_0131
66931009
MedDRA 14.1
10020583
ICD-10-CM Version 2010
E83.52
ICD-9-CM Version 2011
275.42
CTCAE 1105E
E12270
UMLS CUI 2011AA
C0595928
SNOMED CT 2011_0131
10006965
UMLS CUI 2011AA
C2347944
At least one measurable disease manifestation defined as follows:
Description

At least one measurable disease manifestation defined as follows:

Data type

boolean

Alias
UMLS CUI 2011AA
C1513041
UMLS CUI 2011AA
C0205319
SNOMED CT 2011_0131
250255003
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.
Description

For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.

Data type

boolean

Alias
UMLS CUI 2011AA
C0036536
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
C0241988
SNOMED CT 2011_0131
414763006
UMLS CUI 2011AA
C0020852
SNOMED CT 2011_0131
29246005
LOINC Version 232
MTHU005225
UMLS CUI 2011AA
C0020835
SNOMED CT 2011_0131
46046006
LOINC Version 232
MTHU005223
UMLS CUI 2011AA
C0065450
UMLS CUI 2011AA
C1445962
SNOMED CT 2011_0131
412813009
For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
Description

For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0456845
SNOMED CT 2011_0131
277580004
MedDRA 14.1
10029662
UMLS CUI 2011AA
C0225317
SNOMED CT 2011_0131
87784001
LOINC Version 232
MTHU016974
UMLS CUI 2011AA
C0032131
SNOMED CT 2011_0131
10639003
MedDRA 14.1
10035484
ICD-10-CM Version 2010
C90.3
UMLS CUI 2011AA
C0521095
SNOMED CT 2011_0131
436000
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0043299
SNOMED CT 2011_0131
363680008
ICD-9-CM Version 2011
87
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0391861
SNOMED CT 2011_0131
26246006
UMLS CUI 2011AA
C0005954
SNOMED CT 2011_0131
234326005
MedDRA 14.1
10004737
ICD-9-CM Version 2011
41.31
ECOG performance status <= 2 at time of randomization/registration (see Appendix I).
Description

ECOG performance status <= 2 at time of randomization/registration (see Appendix I).

Data type

boolean

Alias
UMLS CUI 2011AA
C1828127
SNOMED CT 2011_0131
424122007
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0034656
Laboratory test results within these ranges within 1 week prior to randomization/registration:
Description

Laboratory test results within these ranges within 1 week prior to randomization/registration:

Data type

boolean

Alias
UMLS CUI 2011AA
C0587081
SNOMED CT 2011_0131
118246004
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C1514721
Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
Description

Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
UMLS CUI 2011AA
C0445107
SNOMED CT 2011_0131
262009000
UMLS CUI 2011AA
C0009392
SNOMED CT 2011_0131
372559001
Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.
Description

Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C1521721
Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
Description

Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).

Data type

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0085862
LOINC Version 232
MTHU013536
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0014822
SNOMED CT 2011_0131
111167001
LOINC Version 232
MTHU004935
Calculated creatinine clearance >= 50 mL/minute.
Description

Calculated creatinine clearance >= 50 mL/minute.

Data type

boolean

Alias
UMLS CUI 2011AA
C0444686
SNOMED CT 2011_0131
258090004
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
Total Bilirubin Measurement
Description

Total bilirubin <= 1.5 mg/dL.

Data type

boolean

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
Description

AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.

Data type

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
Corrected Serum Calcium Measurement
Description

Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).

Data type

boolean

Alias
UMLS CUI 2011AA
C0455288
SNOMED CT 2011_0131
166708003
Female subjects of childbearing potential must:
Description

Female subjects of childbearing potential must:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
Understand that the study medication could have a potential teratogenic risk
Description

Understand that the study medication could have a potential teratogenic risk

Data type

boolean

Alias
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0232910
SNOMED CT 2011_0131
58694006
MedDRA 14.1
10043275
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:
Description

Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205344
SNOMED CT 2011_0131
56136002
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
Contraceptive Implant
Description

Implant

Data type

boolean

Alias
UMLS CUI 2011AA
CL424925
INSERTION OF LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM
Description

Levonorgestrel-releasing intrauterine system (IUS)

Data type

boolean

Alias
UMLS CUI 2011AA
C0994146
Medroxyprogesterone acetate depot
Description

Medroxyprogesterone acetate depot

Data type

boolean

Alias
UMLS CUI 2011AA
C0065864
SNOMED CT 2011_0131
27707001
UMLS CUI 2011AA
C0419530
SNOMED CT 2011_0131
268464009
Tubal sterilization
Description

Tubal sterilisation

Data type

boolean

Alias
UMLS CUI 2011AA
C0038289
SNOMED CT 2011_0131
189234004
Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses
Description

Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses

Data type

boolean

Alias
UMLS CUI 2011AA
C0009253
SNOMED CT 2011_0131
258139002
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
UMLS CUI 2011AA
C0042387
SNOMED CT 2011_0131
22523008
MedDRA 14.1
10047133
ICD-9-CM Version 2011
63.73
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0202533
SNOMED CT 2011_0131
11900001
MedDRA 14.1
10068482
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
Description

Ovulation inhibitory progesterone-only pills (i.e., desogestrel).

Data type

boolean

Alias
UMLS CUI 2011AA
C0029968
UMLS CUI 2011AA
C0033308
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0057558
SNOMED CT 2011_0131
116074007
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
Description

Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0009906
SNOMED CT 2011_0131
346388008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1861172
MedDRA 14.1
10066899
Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
Description

Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0282638
SNOMED CT 2011_0131
422181004
MedDRA 14.1
10064736
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0027947
SNOMED CT 2011_0131
303011007
MedDRA 14.1
10029354
ICD-10-CM Version 2010
D70.9
ICD-9-CM Version 2011
288.00
UMLS CUI 2011AA
C0582147
SNOMED CT 2011_0131
78648007
LOINC Version 232
MTHU013249
Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
Description

Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0038842
SNOMED CT 2011_0131
225313009
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0036667
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
Description

Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0038842
SNOMED CT 2011_0131
225313009
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C1275555
SNOMED CT 2011_0131
396134005
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0038289
SNOMED CT 2011_0131
189234004
Male subjects must
Description

Male subjects must

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
Description

Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0677582
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Description

Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0871414
MedDRA 14.1
10053369
All subjects must
Description

All subjects must

Data type

boolean

Alias
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
Description

Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
CL068143
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
Agree not to share study medication with another person and to return all unused study drug to the investigator.
Description

Agree not to share study medication with another person and to return all unused study drug to the investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415229
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0027361
SNOMED CT 2011_0131
125676002
HL7 V3 2006_05
PSN
UMLS CUI 2011AA
CL415200
UMLS CUI 2011AA
C0445107
SNOMED CT 2011_0131
262009000
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
CL102947
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
Description

Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL415147
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
Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Description

Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
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
Life-expectancy > 3 months.
Description

Life-expectancy > 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
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
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
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
Description

Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).

Data type

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
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.
Description

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.

Data type

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
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.
Description

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.

Data type

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
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
Description

Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.

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
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
Any prior use of lenalidomide.
Description

Any prior use of lenalidomide.

Data type

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
Concurrent use of other anti-cancer agents or treatments.
Description

Concurrent use of other anti-cancer agents or treatments.

Data type

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
Known positive for HIV or infectious hepatitis, type A, B or C.
Description

Known positive for HIV or infectious hepatitis, type A, B or C.

Data type

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
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
Description

Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.

Data type

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
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
Description

Immunotherapy or antibody therapy within 8 weeks before randomization/registration.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021083
major surgery
Description

Major surgery within 4 weeks before randomization/registration.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
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.
Description

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.

Data type

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
Senile cardiac amyloidosis, Cardiac amyloidosis, AS transthyretin amyloidosis
Description

Cardiac amyloidosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0268407
SNOMED CT 2011_0131
16573007
MedDRA 14.1
10007509
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.
Description

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.

Data type

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
Any systemic infection requiring treatment.
Description

Any systemic infection requiring treatment.

Data type

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
Cystitis
Description

Cystitis.

Data type

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
Disturbance of urinary flow.
Description

Disturbance of urinary flow.

Data type

boolean

Alias
UMLS CUI 2011AA
C2699787
UMLS CUI 2011AA
C0012797
SNOMED CT 2011_0131
60309003
MedDRA 14.1
10013523
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Description

Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.

Data type

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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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 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Understand and voluntarily sign an informed consent form.
Item
Understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI 2011AA)
Able to adhere to the study visit schedule and other protocol requirements.
Item
Able to adhere to the study visit schedule and other protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
Item
Previously diagnosed with multiple myeloma based on standard criteria and requires therapy for primary refractory disease or 1st - 3rd relapse because of progressive disease (PD), defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytoma, or hypercalcemia (serum calcium > 11.3 mg/dL), or clinical relapse from CR.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
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)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1514815 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0065450 (UMLS CUI 2011AA)
C0741592 (UMLS CUI 2011AA)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C0032131 (UMLS CUI 2011AA)
10639003 (SNOMED CT 2011_0131)
10035484 (MedDRA 14.1)
C90.3 (ICD-10-CM Version 2010)
C0020437 (UMLS CUI 2011AA)
66931009 (SNOMED CT 2011_0131)
10020583 (MedDRA 14.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE 1105E)
C0595928 (UMLS CUI 2011AA)
10006965 (SNOMED CT 2011_0131)
C2347944 (UMLS CUI 2011AA)
At least one measurable disease manifestation defined as follows:
Item
At least one measurable disease manifestation defined as follows:
boolean
C1513041 (UMLS CUI 2011AA)
C0205319 (UMLS CUI 2011AA)
250255003 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.
Item
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, > 1g/dL IgG M-protein or > 0.5 g/dL IgA) and, where applicable, urine light-chain excretion of >= 200 mg/24 h.
boolean
C0036536 (UMLS CUI 2011AA)
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)
C0241988 (UMLS CUI 2011AA)
414763006 (SNOMED CT 2011_0131)
C0020852 (UMLS CUI 2011AA)
29246005 (SNOMED CT 2011_0131)
MTHU005225 (LOINC Version 232)
C0020835 (UMLS CUI 2011AA)
46046006 (SNOMED CT 2011_0131)
MTHU005223 (LOINC Version 232)
C0065450 (UMLS CUI 2011AA)
C1445962 (UMLS CUI 2011AA)
412813009 (SNOMED CT 2011_0131)
For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
Item
For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or a quantifiable plasma cell infiltration of the bone marrow as determined by bone marrow biopsy.
boolean
C0456845 (UMLS CUI 2011AA)
277580004 (SNOMED CT 2011_0131)
10029662 (MedDRA 14.1)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C0032131 (UMLS CUI 2011AA)
10639003 (SNOMED CT 2011_0131)
10035484 (MedDRA 14.1)
C90.3 (ICD-10-CM Version 2010)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0391861 (UMLS CUI 2011AA)
26246006 (SNOMED CT 2011_0131)
C0005954 (UMLS CUI 2011AA)
234326005 (SNOMED CT 2011_0131)
10004737 (MedDRA 14.1)
41.31 (ICD-9-CM Version 2011)
ECOG performance status <= 2 at time of randomization/registration (see Appendix I).
Item
ECOG performance status <= 2 at time of randomization/registration (see Appendix I).
boolean
C1828127 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Laboratory test results within these ranges within 1 week prior to randomization/registration:
Item
Laboratory test results within these ranges within 1 week prior to randomization/registration:
boolean
C0587081 (UMLS CUI 2011AA)
118246004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C1514721 (UMLS CUI 2011AA)
Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
Item
Absolute neutrophil count >= 1.5 x 109/L without the use of colony stimulating factors within 14 days before the laboratory test.
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
C0445107 (UMLS CUI 2011AA)
262009000 (SNOMED CT 2011_0131)
C0009392 (UMLS CUI 2011AA)
372559001 (SNOMED CT 2011_0131)
Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.
Item
Platelet count >= 75 x 109/L without transfusion support within 14 days before the laboratory test.
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C1521721 (UMLS CUI 2011AA)
Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
Item
Hemoglobin >= 7.5 g/dL (regardless of transfusion support or prior medication with erythropoietin).
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0085862 (UMLS CUI 2011AA)
MTHU013536 (LOINC Version 232)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C1521721 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0014822 (UMLS CUI 2011AA)
111167001 (SNOMED CT 2011_0131)
MTHU004935 (LOINC Version 232)
Calculated creatinine clearance >= 50 mL/minute.
Item
Calculated creatinine clearance >= 50 mL/minute.
boolean
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Total bilirubin <= 1.5 mg/dL.
Item
Total Bilirubin Measurement
boolean
C1278039 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
Item
AST (SGOT) and ALT (SGPT) <= 2,5 x ULN.
boolean
C0004002 (UMLS CUI 2011AA)
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)
Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L).
Item
Corrected Serum Calcium Measurement
boolean
C0455288 (UMLS CUI 2011AA)
166708003 (SNOMED CT 2011_0131)
Female subjects of childbearing potential must:
Item
Female subjects of childbearing potential must:
boolean
C0086287 (UMLS CUI 2011AA)
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)
Understand that the study medication could have a potential teratogenic risk
Item
Understand that the study medication could have a potential teratogenic risk
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0232910 (UMLS CUI 2011AA)
58694006 (SNOMED CT 2011_0131)
10043275 (MedDRA 14.1)
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:
Item
Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception:
boolean
C0680240 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
Implant
Item
Contraceptive Implant
boolean
CL424925 (UMLS CUI 2011AA)
Levonorgestrel-releasing intrauterine system (IUS)
Item
INSERTION OF LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM
boolean
C0994146 (UMLS CUI 2011AA)
Medroxyprogesterone acetate depot
Item
Medroxyprogesterone acetate depot
boolean
C0065864 (UMLS CUI 2011AA)
27707001 (SNOMED CT 2011_0131)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
Tubal sterilisation
Item
Tubal sterilization
boolean
C0038289 (UMLS CUI 2011AA)
189234004 (SNOMED CT 2011_0131)
Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses
Item
Sexual intercourse with a vasectomised male partner only. Vasectomy must be confirmed by two negative semen analyses
boolean
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
C0750484 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0202533 (UMLS CUI 2011AA)
11900001 (SNOMED CT 2011_0131)
10068482 (MedDRA 14.1)
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
Item
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
boolean
C0029968 (UMLS CUI 2011AA)
C0033308 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0057558 (UMLS CUI 2011AA)
116074007 (SNOMED CT 2011_0131)
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
Item
Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception
boolean
C0009906 (UMLS CUI 2011AA)
346388008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1861172 (UMLS CUI 2011AA)
10066899 (MedDRA 14.1)
Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
Item
Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
boolean
C0282638 (UMLS CUI 2011AA)
422181004 (SNOMED CT 2011_0131)
10064736 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0027947 (UMLS CUI 2011AA)
303011007 (SNOMED CT 2011_0131)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288.00 (ICD-9-CM Version 2011)
C0582147 (UMLS CUI 2011AA)
78648007 (SNOMED CT 2011_0131)
MTHU013249 (LOINC Version 232)
Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
Item
Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
boolean
C0680240 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0038842 (UMLS CUI 2011AA)
225313009 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C1524031 (UMLS CUI 2011AA)
C0036667 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
Item
Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
boolean
C0680240 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0038842 (UMLS CUI 2011AA)
225313009 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C1275555 (UMLS CUI 2011AA)
396134005 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0038289 (UMLS CUI 2011AA)
189234004 (SNOMED CT 2011_0131)
Male subjects must
Item
Male subjects must
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0681850 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
Item
Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
boolean
C0680240 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
Item
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
All subjects must
Item
All subjects must
boolean
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0681850 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
Item
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
boolean
C0680240 (UMLS CUI 2011AA)
CL068143 (UMLS CUI 2011AA)
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
Agree not to share study medication with another person and to return all unused study drug to the investigator.
Item
Agree not to share study medication with another person and to return all unused study drug to the investigator.
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL415229 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
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)
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
Item
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
boolean
C0012634 (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)
Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Item
Able and willing to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
boolean
C0085732 (UMLS CUI 2011AA)
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)
Life-expectancy > 3 months.
Item
Life-expectancy > 3 months.
boolean
C0023671 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (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)
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)
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
Item
Females, who are pregnant, calculate to get pregnant or are breast feeding (Lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0086287 (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)
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.
Item
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.
boolean
C0348080 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C1516879 (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)
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
Item
Known hypersensitivity to thalidomide, dexamethasone, or cyclophosphamide or similar drugs.
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)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
Any prior use of lenalidomide.
Item
Any prior use of lenalidomide.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
Concurrent use of other anti-cancer agents or treatments.
Item
Concurrent use of other anti-cancer agents or treatments.
boolean
C0205420 (UMLS CUI 2011AA)
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)
Known positive for HIV or infectious hepatitis, type A, B or C.
Item
Known positive for HIV or infectious hepatitis, type A, B or C.
boolean
C0019699 (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)
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
Item
Any other chemotherapy or high-dose dexamethasone within 4 weeks before randomization/registration.
boolean
C0205394 (UMLS CUI 2011AA)
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)
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
Item
Immunotherapy or antibody therapy within 8 weeks before randomization/registration.
boolean
C0021083 (UMLS CUI 2011AA)
Major surgery within 4 weeks before randomization/registration.
Item
major surgery
boolean
C0679637 (UMLS CUI 2011AA)
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.
Item
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.
boolean
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)
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)
Cardiac amyloidosis.
Item
Senile cardiac amyloidosis, Cardiac amyloidosis, AS transthyretin amyloidosis
boolean
C0268407 (UMLS CUI 2011AA)
16573007 (SNOMED CT 2011_0131)
10007509 (MedDRA 14.1)
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.
Item
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.
boolean
C1868885 (UMLS CUI 2011AA)
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)
Any systemic infection requiring treatment.
Item
Any systemic infection requiring treatment.
boolean
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Cystitis.
Item
Cystitis
boolean
C0010692 (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)
Disturbance of urinary flow.
Item
Disturbance of urinary flow.
boolean
C2699787 (UMLS CUI 2011AA)
C0012797 (UMLS CUI 2011AA)
60309003 (SNOMED CT 2011_0131)
10013523 (MedDRA 14.1)
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
Item
Unable or unwilling to take heparin (usually low-molecular weight - LMWH) or low acetylsalicylic acid (100 mg) daily as prophylactic anticoagulation.
boolean
C1299582 (UMLS CUI 2011AA)
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)
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