ID
4553
Beschreibung
ODM derived from http://clinicaltrials.gov/show/NCT00478777
Link
http://clinicaltrials.gov/show/NCT00478777
Stichworte
Versionen (4)
- 11.12.13 11.12.13 - Martin Dugas
- 14.04.14 14.04.14 - Julian Varghese
- 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
- 20.09.21 20.09.21 -
Hochgeladen am
11. Dezember 2013
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0 Legacy
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility NCT00478777 Relapsed or Refractory Multiple Myeloma
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Beschreibung
The presence of any of the following will exclude a subject from study enrollment:
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C1516879
Beschreibung
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1699700
- HL7 V3 2006_05
- MEDCCAT
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
- UMLS CUI 2011AA
- C0004936
- SNOMED CT 2011_0131
- 74732009
- MedDRA 14.1
- 10037174
- ICD-10-CM Version 2010
- F99
- ICD-9-CM Version 2011
- 290-319.99
- UMLS CUI 2011AA
- C2700409
- UMLS CUI 2011AA
- C2348583
Beschreibung
Pregnant or lactating females.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C2828358
- UMLS CUI 2011AA
- CL414917
Beschreibung
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0683481
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C1273101
- SNOMED CT 2011_0131
- 395659009
- UMLS CUI 2011AA
- C0681873
Beschreibung
Any of the following laboratory abnormalities:
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
Beschreibung
Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0948762
- MedDRA 14.1
- 10052033
Beschreibung
Platelet count <75,000/mm^3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
- UMLS CUI 2011AA
- C1180059
- LOINC Version 232
- MTHU026777
- UMLS CUI 2011AA
- C0032112
- SNOMED CT 2011_0131
- 113335003
- LOINC Version 232
- MTHU011655
Beschreibung
Platelet count <30,000/mm^3 (30x10^9/L) for subjects in whom >=50% of bone marrow nucleated cells are plasma cells.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1287267
- SNOMED CT 2011_0131
- 365632008
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
- UMLS CUI 2011AA
- C1180059
- LOINC Version 232
- MTHU026777
- UMLS CUI 2011AA
- C0032112
- SNOMED CT 2011_0131
- 113335003
- LOINC Version 232
- MTHU011655
Beschreibung
Serum creatinine >2.5 mg/dL (221 µmol/L)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0201976
- SNOMED CT 2011_0131
- 113075003
- MedDRA 14.1
- 10040230
Beschreibung
Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0201899
- SNOMED CT 2011_0131
- 45896001
- MedDRA 14.1
- 10003476
- UMLS CUI 2011AA
- C0201836
- SNOMED CT 2011_0131
- 34608000
- MedDRA 14.1
- 10001546
- UMLS CUI 2011AA
- C0376147
- UMLS CUI 2011AA
- C1519815
Beschreibung
Serum total bilirubin >2.0 mg/dL (34 µmol/L)
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1278039
- SNOMED CT 2011_0131
- 313840000
- MedDRA 14.1
- 10040162
Beschreibung
Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >=1 year.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0026764
- SNOMED CT 2011_0131
- 109989006
- MedDRA 14.1
- 10028228
- ICD-10-CM Version 2010
- C90.0
- ICD-9-CM Version 2011
- 203.0
- UMLS CUI 2011AA
- C1554961
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0154084
- SNOMED CT 2011_0131
- 189336000
- MedDRA 14.1
- 10006189
- ICD-10-CM Version 2010
- D05
- ICD-9-CM Version 2011
- 233.0
- UMLS CUI 2011AA
- C0242793
Beschreibung
Prior history of stroke and/or thromboembolic event
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0038454
- SNOMED CT 2011_0131
- 230690007
- MedDRA 14.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE 1105E
- E12826
- UMLS CUI 2011AA
- C0857496
- MedDRA 14.1
- 10043565
Beschreibung
Known hypersensitivity to thalidomide or dexamethasone.
Datentyp
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
Beschreibung
Prior history of uncontrollable side effects to dexamethasone therapy.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0262926
- SNOMED CT 2011_0131
- 417662000
- LOINC Version 232
- MTHU027722
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- CL330043
- UMLS CUI 2011AA
- C0011777
- SNOMED CT 2011_0131
- 372584003
- LOINC Version 232
- MTHU004621
Beschreibung
The development of a desquamating rash while taking thalidomide.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C1559142
- CTCAE 1105E
- MTHU117394
- UMLS CUI 2011AA
- C1512806
- UMLS CUI 2011AA
- C0039736
- SNOMED CT 2011_0131
- 78702007
Beschreibung
Neuropathy >= Grade 2.
Datentyp
boolean
Alias
- UMLS CUI 2011AA
- C0442874
- SNOMED CT 2011_0131
- 386033004
- MedDRA 14.1
- 10029328
- UMLS CUI 2011AA
- C0441800
- SNOMED CT 2011_0131
- 258349007
- LOINC Version 232
- MTHU003112
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
66216009 (SNOMED CT 2011_0131)
C0439656 (UMLS CUI 2011AA)
255375007 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0009797 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0009797 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C0039798 (UMLS CUI 2011AA)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
C0009429 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
CL324441 (UMLS CUI 2011AA)
C0599938 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI 2011AA)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL324441 (UMLS CUI 2011AA)
C0030490 (UMLS CUI 2011AA)
49010003 (SNOMED CT 2011_0131)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0042036 (UMLS CUI 2011AA)
78014005 (SNOMED CT 2011_0131)
MTHU001343 (LOINC Version 232)
CL423120 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL068143 (UMLS CUI 2011AA)
C0009253 (UMLS CUI 2011AA)
258139002 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C2700409 (UMLS CUI 2011AA)
C2348583 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
CL414917 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0683481 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
C1273101 (UMLS CUI 2011AA)
395659009 (SNOMED CT 2011_0131)
C0681873 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
365632008 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C1180059 (UMLS CUI 2011AA)
MTHU026777 (LOINC Version 232)
C0032112 (UMLS CUI 2011AA)
113335003 (SNOMED CT 2011_0131)
MTHU011655 (LOINC Version 232)
365632008 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C1180059 (UMLS CUI 2011AA)
MTHU026777 (LOINC Version 232)
C0032112 (UMLS CUI 2011AA)
113335003 (SNOMED CT 2011_0131)
MTHU011655 (LOINC Version 232)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
45896001 (SNOMED CT 2011_0131)
10003476 (MedDRA 14.1)
C0201836 (UMLS CUI 2011AA)
34608000 (SNOMED CT 2011_0131)
10001546 (MedDRA 14.1)
C0376147 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
313840000 (SNOMED CT 2011_0131)
10040162 (MedDRA 14.1)
392521001 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C1554961 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0154084 (UMLS CUI 2011AA)
189336000 (SNOMED CT 2011_0131)
10006189 (MedDRA 14.1)
D05 (ICD-10-CM Version 2010)
233.0 (ICD-9-CM Version 2011)
C0242793 (UMLS CUI 2011AA)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0857496 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
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)
417662000 (SNOMED CT 2011_0131)
MTHU027722 (LOINC Version 232)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL330043 (UMLS CUI 2011AA)
C0011777 (UMLS CUI 2011AA)
372584003 (SNOMED CT 2011_0131)
MTHU004621 (LOINC Version 232)
MTHU117394 (CTCAE 1105E)
C1512806 (UMLS CUI 2011AA)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
386033004 (SNOMED CT 2011_0131)
10029328 (MedDRA 14.1)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)