ID

43426

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00689936

Länk

http://clinicaltrials.gov/show/NCT00689936

Nyckelord

Versioner (3)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2014-04-16 2014-04-16 - Julian Varghese
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00689936 Multiple Myeloma

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Must understand and voluntarily sign informed consent form
Beskrivning

Must understand and voluntarily sign informed consent form

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Age ≥ 18 years at the time of signing consent
Beskrivning

Age ≥ 18 years at the time of signing consent

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C1511481
LOINC Version 232
MTHU035862
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
Beskrivning

Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
CL384716
MM diagnostic criteria (all 3 required)
Beskrivning

MM diagnostic criteria (all 3 required)

Datatyp

boolean

Alias
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
C0679228
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C1514873
Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
Beskrivning

Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1522642
UMLS CUI 2011AA
C0032112
SNOMED CT 2011_0131
113335003
LOINC Version 232
MTHU011655
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0005558
SNOMED CT 2011_0131
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0032131
SNOMED CT 2011_0131
10639003
MedDRA 14.1
10035484
ICD-10-CM Version 2010
C90.3
Monoclonal protein present in the serum and/or urine
Beskrivning

Monoclonal protein present in the serum and/or urine

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0241988
SNOMED CT 2011_0131
414763006
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
Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis
Beskrivning

Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C0349410
SNOMED CT 2011_0131
251526004
UMLS CUI 2011AA
C0595928
SNOMED CT 2011_0131
10006965
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0002871
SNOMED CT 2011_0131
271737000
MedDRA 14.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE 1105E
E10010
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C0205307
SNOMED CT 2011_0131
17621005
HL7 V3 2006_05
N
UMLS CUI 2011AA
C0741592
UMLS CUI 2011AA
C0029456
SNOMED CT 2011_0131
64859006
MedDRA 14.1
10031282
LOINC Version 232
MTHU020796
ICD-10-CM Version 2010
M81.0
ICD-9-CM Version 2011
733.00
CTCAE 1105E
E12508
AND have measurable disease by protein electrophoresis analyses as defined by the following
Beskrivning

AND have measurable disease by protein electrophoresis analyses as defined by the following

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1513041
UMLS CUI 2011AA
C0201719
SNOMED CT 2011_0131
82962001
MedDRA 14.1
10014467
UMLS CUI 2011AA
C0002778
SNOMED CT 2011_0131
272389005
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
Beskrivning

IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020852
SNOMED CT 2011_0131
29246005
LOINC Version 232
MTHU005225
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
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0443737
SNOMED CT 2011_0131
259804009
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
Beskrivning

IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020835
SNOMED CT 2011_0131
46046006
LOINC Version 232
MTHU005223
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
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
Beskrivning

IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020861
SNOMED CT 2011_0131
74889000
LOINC Version 232
MTHU004563
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
C0700271
UMLS CUI 2011AA
C0741592
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1997417
SNOMED CT 2011_0131
429646003
UMLS CUI 2011AA
C0581652
SNOMED CT 2011_0131
303937007
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
Beskrivning

IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020843
SNOMED CT 2011_0131
11151008
LOINC Version 232
MTHU011895
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
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
Beskrivning

Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021038
SNOMED CT 2011_0131
87316007
LOINC Version 232
MTHU002541
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
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C0042036
SNOMED CT 2011_0131
78014005
LOINC Version 232
MTHU001343
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because
Beskrivning

AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
The patient declines to undergo stem cell transplantation or
Beskrivning

The patient declines to undergo stem cell transplantation or

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1705116
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
Stem cell transplantation is not available to the patient due to cost or other reasons
Beskrivning

Stem cell transplantation is not available to the patient due to cost or other reasons

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1504389
MedDRA 14.1
10063581
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0470187
SNOMED CT 2011_0131
103328004
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0010186
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0392360
SNOMED CT 2011_0131
410666004 230165009
LOINC Version 232
MTHU008862
ECOG Status <= 2
Beskrivning

ECOG performance status <= 2

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Able to adhere to the study visit schedule and other protocol requirements
Beskrivning

Able to adhere to the study visit schedule and other protocol requirements

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
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
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1709747
Females of child-bearing potential (FCBP)^2
Beskrivning

Females of child-bearing potential (FCBP)^2

Datatyp

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
C0205448
SNOMED CT 2011_0131
19338005
Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
Beskrivning

Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
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
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1144149
SNOMED CT 2011_0131
421471009
UMLS CUI 2011AA
C0332287
SNOMED CT 2011_0131
20401003
UMLS CUI 2011AA
C1708745
UMLS CUI 2011AA
C0011777
SNOMED CT 2011_0131
372584003
LOINC Version 232
MTHU004621
UMLS CUI 2011AA
C1881367
UMLS CUI 2011AA
C0025241
SNOMED CT 2011_0131
387297002
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
C0039736
SNOMED CT 2011_0131
78702007
UMLS CUI 2011AA
C1881501
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1881367
UMLS CUI 2011AA
C1881501
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1881367
UMLS CUI 2011AA
C1881501
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0032976
SNOMED CT 2011_0131
74036000
MedDRA 14.1
10036572
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
CL421124
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
Beskrivning

Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0026528
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
CL068143
UMLS CUI 2011AA
C0019421
SNOMED CT 2011_0131
20430005
MedDRA 14.1
10020018
UMLS CUI 2011AA
C0009253
SNOMED CT 2011_0131
258139002
UMLS CUI 2011AA
C1709940
UMLS CUI 2011AA
C0332177
SNOMED CT 2011_0131
89185003
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0549178
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C1512900
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C0457454
SNOMED CT 2011_0131
278308006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
männlich
Beskrivning

Male Patients

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
Beskrivning

Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0036864
SNOMED CT 2011_0131
363903009
UMLS CUI 2011AA
C0221190
SNOMED CT 2011_0131
76933008
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
C0042387
SNOMED CT 2011_0131
22523008
MedDRA 14.1
10047133
ICD-9-CM Version 2011
63.73
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C1512900
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C1880019
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy
Beskrivning

Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0871414
MedDRA 14.1
10053369
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
CL421124
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
All patients must
Beskrivning

All patients must

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Have an understanding that the study drug could have a potential teratogenic risk
Beskrivning

Have an understanding that the study drug could have a potential teratogenic risk

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332149
SNOMED CT 2011_0131
371930009
UMLS CUI 2011AA
C0232910
SNOMED CT 2011_0131
58694006
MedDRA 14.1
10043275
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C0005794
SNOMED CT 2011_0131
25179006
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0457454
SNOMED CT 2011_0131
278308006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure
Beskrivning

Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415229
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
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
C0444868
SNOMED CT 2011_0131
261675009
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
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1522154
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C1882442
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0015965
LOINC Version 232
MTHU002972
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Beskrivning

Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0012544
SNOMED CT 2011_0131
372907000
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1806781
SNOMED CT 2011_0131
367450005
UMLS CUI 2011AA
C0750729
SNOMED CT 2011_0131
288524001
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0011777
SNOMED CT 2011_0131
372584003
LOINC Version 232
MTHU004621
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0034656
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Beskrivning

Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
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
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
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
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
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0003873
SNOMED CT 2011_0131
69896004
MedDRA 14.1
10039073
ICD-10-CM Version 2010
M06.9
ICD-9-CM Version 2011
714.0
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C1706712
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
Pregnant or lactating females
Beskrivning

Pregnant or lactating females

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Any of the following laboratory abnormalities
Beskrivning

Any of the following laboratory abnormalities

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1704258
Absolute Neutrophil Count
Beskrivning

Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
Beskrivning

Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1879316
SNOMED CT 2011_0131
5447007
MedDRA 14.1
10066152
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
Beskrivning

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

Datatyp

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
CL384738
UMLS CUI 2011AA
C1519815
Renal failure requiring hemodialysis or peritoneal dialysis.
Beskrivning

Renal failure requiring hemodialysis or peritoneal dialysis.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0019004
SNOMED CT 2011_0131
302497006
MedDRA 14.1
10018875
ICD-10-CM Version 2010
E71.43
ICD-9-CM Version 2011
39.95
UMLS CUI 2011AA
C0031139
SNOMED CT 2011_0131
71192002
MedDRA 14.1
10034660
ICD-9-CM Version 2011
54.98
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
Beskrivning

Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
CL411789
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
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
Basalzellenkarzinom
Beskrivning

Basal cell carcinoma of the skin

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
Plattenepithelkarzinom
Beskrivning

Squamous cell carcinoma of the skin

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Carcinoma in situ of uterine cervix
Beskrivning

Carcinoma in situ of the cervix

Datatyp

boolean

Alias
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
Stage 0 Breast Carcinoma
Beskrivning

Carcinoma in situ of the breast

Datatyp

boolean

Alias
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
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
Beskrivning

Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0444507
SNOMED CT 2011_0131
261087003
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0243095
UMLS CUI 2011AA
C0600139
SNOMED CT 2011_0131
254900004
MedDRA 14.1
10036921
UMLS CUI 2011AA
C0809869
SNOMED CT 2011_0131
399566009
LOINC Version 232
MTHU010377
UMLS CUI 2011AA
C0475383
SNOMED CT 2011_0131
261646003
UMLS CUI 2011AA
C0475385
SNOMED CT 2011_0131
261649005
Patients who are unable or unwilling to undergo antithrombotic therapy.
Beskrivning

Patients who are unable or unwilling to undergo antithrombotic therapy.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1704311
UMLS CUI 2011AA
C0039798
Peripheral neuropathy of > grade 2 severity.
Beskrivning

Peripheral neuropathy of > grade 2 severity.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
C0439793
SNOMED CT 2011_0131
246112005
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C1522446
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
Beskrivning

Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
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
UMLS CUI 2011AA
C0268381
SNOMED CT 2011_0131
23132008
MedDRA 14.1
10036673
UMLS CUI 2011AA
C0021038
SNOMED CT 2011_0131
87316007
LOINC Version 232
MTHU002541
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0231242
SNOMED CT 2011_0131
255302009
UMLS CUI 2011AA
C0002726
SNOMED CT 2011_0131
17602002
MedDRA 14.1
10002022
LOINC Version 232
E85
ICD-10-CM Version 2010
277.3
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
Beskrivning

A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
C0349410
SNOMED CT 2011_0131
251526004
UMLS CUI 2011AA
C0521114
SNOMED CT 2011_0131
84638005, 27789000
UMLS CUI 2011AA
C0243132
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0277785
SNOMED CT 2011_0131
386585008
UMLS CUI 2011AA
C0008902
SNOMED CT 2011_0131
278201002
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
CL324441
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Beskrivning

A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Datatyp

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
C0036864
SNOMED CT 2011_0131
363903009
UMLS CUI 2011AA
C0205286
SNOMED CT 2011_0131
34071009
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0278321
SNOMED CT 2011_0131
76876009
MedDRA 14.1
10030339
ICD-9-CM Version 2011
65.51
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205296
SNOMED CT 2011_0131
510009
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0002453
SNOMED CT 2011_0131
14302001
MedDRA 14.1
10001928
ICD-10-CM Version 2010
N91.2
ICD-9-CM Version 2011
626.0
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0332196
SNOMED CT 2011_0131
77765009
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0025344
SNOMED CT 2011_0131
248957007
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0040223
SNOMED CT 2011_0131
410670007
LOINC Version 232
MTHU009151
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C1707491
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
Must understand and voluntarily sign informed consent form
Item
Must understand and voluntarily sign informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
Age ≥ 18 years at the time of signing consent
Item
Age ≥ 18 years at the time of signing consent
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C1511481 (UMLS CUI 2011AA)
MTHU035862 (LOINC Version 232)
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
Item
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0231220 (UMLS CUI 2011AA)
264931009 (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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1704788 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
CL384716 (UMLS CUI 2011AA)
MM diagnostic criteria (all 3 required)
Item
MM diagnostic criteria (all 3 required)
boolean
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)
C0679228 (UMLS CUI 2011AA)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
Item
Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
boolean
C1522642 (UMLS CUI 2011AA)
C0032112 (UMLS CUI 2011AA)
113335003 (SNOMED CT 2011_0131)
MTHU011655 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0032131 (UMLS CUI 2011AA)
10639003 (SNOMED CT 2011_0131)
10035484 (MedDRA 14.1)
C90.3 (ICD-10-CM Version 2010)
Monoclonal protein present in the serum and/or urine
Item
Monoclonal protein present in the serum and/or urine
boolean
C0241988 (UMLS CUI 2011AA)
414763006 (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)
Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis
Item
Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis
boolean
CL324441 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C0349410 (UMLS CUI 2011AA)
251526004 (SNOMED CT 2011_0131)
C0595928 (UMLS CUI 2011AA)
10006965 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C0205307 (UMLS CUI 2011AA)
17621005 (SNOMED CT 2011_0131)
N (HL7 V3 2006_05)
C0741592 (UMLS CUI 2011AA)
C0029456 (UMLS CUI 2011AA)
64859006 (SNOMED CT 2011_0131)
10031282 (MedDRA 14.1)
MTHU020796 (LOINC Version 232)
M81.0 (ICD-10-CM Version 2010)
733.00 (ICD-9-CM Version 2011)
E12508 (CTCAE 1105E)
AND have measurable disease by protein electrophoresis analyses as defined by the following
Item
AND have measurable disease by protein electrophoresis analyses as defined by the following
boolean
C1513041 (UMLS CUI 2011AA)
C0201719 (UMLS CUI 2011AA)
82962001 (SNOMED CT 2011_0131)
10014467 (MedDRA 14.1)
C0002778 (UMLS CUI 2011AA)
272389005 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
Item
IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
boolean
C0020852 (UMLS CUI 2011AA)
29246005 (SNOMED CT 2011_0131)
MTHU005225 (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)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0443737 (UMLS CUI 2011AA)
259804009 (SNOMED CT 2011_0131)
C0700271 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
Item
IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
boolean
C0020835 (UMLS CUI 2011AA)
46046006 (SNOMED CT 2011_0131)
MTHU005223 (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)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0700271 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
Item
IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
boolean
C0020861 (UMLS CUI 2011AA)
74889000 (SNOMED CT 2011_0131)
MTHU004563 (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)
C0700271 (UMLS CUI 2011AA)
C0741592 (UMLS CUI 2011AA)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1997417 (UMLS CUI 2011AA)
429646003 (SNOMED CT 2011_0131)
C0581652 (UMLS CUI 2011AA)
303937007 (SNOMED CT 2011_0131)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0700271 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
Item
IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
boolean
C0020843 (UMLS CUI 2011AA)
11151008 (SNOMED CT 2011_0131)
MTHU011895 (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)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0700271 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
Item
Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
boolean
C0021038 (UMLS CUI 2011AA)
87316007 (SNOMED CT 2011_0131)
MTHU002541 (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)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0700271 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because
Item
AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0750557 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
The patient declines to undergo stem cell transplantation or
Item
The patient declines to undergo stem cell transplantation or
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
Stem cell transplantation is not available to the patient due to cost or other reasons
Item
Stem cell transplantation is not available to the patient due to cost or other reasons
boolean
C1504389 (UMLS CUI 2011AA)
10063581 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0470187 (UMLS CUI 2011AA)
103328004 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C0010186 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0392360 (UMLS CUI 2011AA)
410666004 230165009 (SNOMED CT 2011_0131)
MTHU008862 (LOINC Version 232)
ECOG performance status <= 2
Item
ECOG Status <= 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
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)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1709747 (UMLS CUI 2011AA)
Females of child-bearing potential (FCBP)^2
Item
Females of child-bearing potential (FCBP)^2
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
Item
Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
boolean
C0680240 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
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)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1144149 (UMLS CUI 2011AA)
421471009 (SNOMED CT 2011_0131)
C0332287 (UMLS CUI 2011AA)
20401003 (SNOMED CT 2011_0131)
C1708745 (UMLS CUI 2011AA)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C1881367 (UMLS CUI 2011AA)
C0025241 (UMLS CUI 2011AA)
387297002 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C1881501 (UMLS CUI 2011AA)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1881367 (UMLS CUI 2011AA)
C1881501 (UMLS CUI 2011AA)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1881367 (UMLS CUI 2011AA)
C1881501 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0032976 (UMLS CUI 2011AA)
74036000 (SNOMED CT 2011_0131)
10036572 (MedDRA 14.1)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
CL421124 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0549178 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
Item
Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
boolean
C0026528 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
CL068143 (UMLS CUI 2011AA)
C0019421 (UMLS CUI 2011AA)
20430005 (SNOMED CT 2011_0131)
10020018 (MedDRA 14.1)
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
C1709940 (UMLS CUI 2011AA)
C0332177 (UMLS CUI 2011AA)
89185003 (SNOMED CT 2011_0131)
CL414906 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0549178 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1948053 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C1512900 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Male Patients
Item
männlich
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
Item
Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
boolean
C0680240 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0036864 (UMLS CUI 2011AA)
363903009 (SNOMED CT 2011_0131)
C0221190 (UMLS CUI 2011AA)
76933008 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C1512900 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1880019 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy
Item
Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0871414 (UMLS CUI 2011AA)
10053369 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
CL421124 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
All patients must
Item
All patients must
boolean
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Have an understanding that the study drug could have a potential teratogenic risk
Item
Have an understanding that the study drug could have a potential teratogenic risk
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
C0232910 (UMLS CUI 2011AA)
58694006 (SNOMED CT 2011_0131)
10043275 (MedDRA 14.1)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
Item
Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
boolean
C0680240 (UMLS CUI 2011AA)
C0870186 (UMLS CUI 2011AA)
C0005794 (UMLS CUI 2011AA)
25179006 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure
Item
Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
CL415229 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1522154 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C1882442 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0015965 (UMLS CUI 2011AA)
MTHU002972 (LOINC Version 232)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
Item
Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., <= the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C0012544 (UMLS CUI 2011AA)
372907000 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1806781 (UMLS CUI 2011AA)
367450005 (SNOMED CT 2011_0131)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
CL415123 (UMLS CUI 2011AA)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Item
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0750557 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
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)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (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)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0003873 (UMLS CUI 2011AA)
69896004 (SNOMED CT 2011_0131)
10039073 (MedDRA 14.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C1706712 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (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)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Any of the following laboratory abnormalities
Item
Any of the following laboratory abnormalities
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
Item
Absolute Neutrophil Count
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
Item
Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
boolean
C1518422 (UMLS CUI 2011AA)
C1879316 (UMLS CUI 2011AA)
5447007 (SNOMED CT 2011_0131)
10066152 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
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
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)
CL384738 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
Renal failure requiring hemodialysis or peritoneal dialysis.
Item
Renal failure requiring hemodialysis or peritoneal dialysis.
boolean
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0019004 (UMLS CUI 2011AA)
302497006 (SNOMED CT 2011_0131)
10018875 (MedDRA 14.1)
E71.43 (ICD-10-CM Version 2010)
39.95 (ICD-9-CM Version 2011)
C0031139 (UMLS CUI 2011AA)
71192002 (SNOMED CT 2011_0131)
10034660 (MedDRA 14.1)
54.98 (ICD-9-CM Version 2011)
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
Item
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
CL411789 (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
Basal cell carcinoma of the skin
Item
Basalzellenkarzinom
boolean
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
Squamous cell carcinoma of the skin
Item
Plattenepithelkarzinom
boolean
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Carcinoma in situ of the cervix
Item
Carcinoma in situ of uterine cervix
boolean
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)
Carcinoma in situ of the breast
Item
Stage 0 Breast Carcinoma
boolean
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)
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
Item
Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
boolean
C0444507 (UMLS CUI 2011AA)
261087003 (SNOMED CT 2011_0131)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0243095 (UMLS CUI 2011AA)
C0600139 (UMLS CUI 2011AA)
254900004 (SNOMED CT 2011_0131)
10036921 (MedDRA 14.1)
C0809869 (UMLS CUI 2011AA)
399566009 (SNOMED CT 2011_0131)
MTHU010377 (LOINC Version 232)
C0475383 (UMLS CUI 2011AA)
261646003 (SNOMED CT 2011_0131)
C0475385 (UMLS CUI 2011AA)
261649005 (SNOMED CT 2011_0131)
Patients who are unable or unwilling to undergo antithrombotic therapy.
Item
Patients who are unable or unwilling to undergo antithrombotic therapy.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1704311 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
Peripheral neuropathy of > grade 2 severity.
Item
Peripheral neuropathy of > grade 2 severity.
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
C0439793 (UMLS CUI 2011AA)
246112005 (SNOMED CT 2011_0131)
CL384738 (UMLS CUI 2011AA)
C1522446 (UMLS CUI 2011AA)
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
Item
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
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)
C0268381 (UMLS CUI 2011AA)
23132008 (SNOMED CT 2011_0131)
10036673 (MedDRA 14.1)
C0021038 (UMLS CUI 2011AA)
87316007 (SNOMED CT 2011_0131)
MTHU002541 (LOINC Version 232)
CL324441 (UMLS CUI 2011AA)
C0231242 (UMLS CUI 2011AA)
255302009 (SNOMED CT 2011_0131)
C0002726 (UMLS CUI 2011AA)
17602002 (SNOMED CT 2011_0131)
10002022 (MedDRA 14.1)
E85 (LOINC Version 232)
277.3 (ICD-10-CM Version 2010)
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
Item
A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0349410 (UMLS CUI 2011AA)
251526004 (SNOMED CT 2011_0131)
C0521114 (UMLS CUI 2011AA)
84638005, 27789000 (SNOMED CT 2011_0131)
C0243132 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0008902 (UMLS CUI 2011AA)
278201002 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Item
A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0036864 (UMLS CUI 2011AA)
363903009 (SNOMED CT 2011_0131)
C0205286 (UMLS CUI 2011AA)
34071009 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0278321 (UMLS CUI 2011AA)
76876009 (SNOMED CT 2011_0131)
10030339 (MedDRA 14.1)
65.51 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0205296 (UMLS CUI 2011AA)
510009 (SNOMED CT 2011_0131)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0002453 (UMLS CUI 2011AA)
14302001 (SNOMED CT 2011_0131)
10001928 (MedDRA 14.1)
N91.2 (ICD-10-CM Version 2010)
626.0 (ICD-9-CM Version 2011)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0025344 (UMLS CUI 2011AA)
248957007 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1707491 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
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