ID

43078

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01332968

Link

http://clinicaltrials.gov/show/NCT01332968

Stichworte

Versionen (3)
  1. 21.03.13 21.03.13 - Martin Dugas
  2. 19.04.14 19.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility DRKS00003834 NCT01332968 Non-Hodgkin's Lymphoma

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

age at least 18 Years
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adult (person)
Beschreibung

Adult patients, >/= 18 years of age

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
Beschreibung

CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0054946
SNOMED CT 2011_0131
82753007
LOINC Version 232
MTHU001655
UMLS CUI 2011AA
C0234227
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0024301
SNOMED CT 2011_0131
277618009, 308121000
MedDRA 14.1
10061170
ICD-10-CM Version 2010
C82
ICD-9-CM Version 2011
202.0
UMLS CUI 2011AA
C0349632
SNOMED CT 2011_0131
128802003
MedDRA 14.1
10062113
ICD-10-CM Version 2010
C83.0
UMLS CUI 2011AA
C0855139
SNOMED CT 2011_0131
397349003, 277623009
MedDRA 14.1
10029460
ICD-10-CM Version 2010
C83.0
UMLS CUI 2011AA
C0242647
SNOMED CT 2011_0131
445269007
MedDRA 14.1
10021435
ICD-10-CM Version 2010
C88.4
Stage III or IV disease, or Stage II bulky disease, requiring treatment
Beschreibung

Stage III or IV disease, or Stage II bulky disease, requiring treatment

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0441771
SNOMED CT 2011_0131
258224005
UMLS CUI 2011AA
C0441772
SNOMED CT 2011_0131
258228008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0441767
SNOMED CT 2011_0131
258219007
UMLS CUI 2011AA
C1511341
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0039798
At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
Beschreibung

At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1705052
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Beschreibung

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1520224
Adequate hematologic function
Beschreibung

Adequate hematologic function

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0221130
Exclusion Criteria
Beschreibung

Exclusion Criteria

Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Beschreibung

Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0280803
SNOMED CT 2011_0131
307649006
MedDRA 14.1
10007953
ICD-9-CM Version 2011
200.5
UMLS CUI 2011AA
C2213017
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1510411
UMLS CUI 2011AA
C0549177
SNOMED CT 2011_0131
255509001
UMLS CUI 2011AA
C0079731
SNOMED CT 2011_0131
109979007
MedDRA 14.1
10003899
UMLS CUI 2011AA
C0079744
SNOMED CT 2011_0131
46732000
MedDRA 14.1
10012818
ICD-10-CM Version 2010
C83.3
Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
Beschreibung

Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2853827
ICD-10-CM Version 2010
C82.4
UMLS CUI 2011AA
C0855095
SNOMED CT 2011_0131
302841002
MedDRA 14.1
10003908
UMLS CUI 2011AA
C0024419
SNOMED CT 2011_0131
190818004
MedDRA 14.1
10047801
ICD-10-CM Version 2010
C88.0
ICD-9-CM Version 2011
273.3
Ann Arbor Stage I disease
Beschreibung

Ann Arbor Stage I disease

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0474949
SNOMED CT 2011_0131
254374001
UMLS CUI 2011AA
C0441766
SNOMED CT 2011_0131
258215001
LOINC Version 232
MTHU035012
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
Beschreibung

History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol

Datentyp

boolean

Alias
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0002792
SNOMED CT 2011_0131
39579001
MedDRA 14.1
10002199
ICD-10-CM Version 2010
T78.2
CTCAE 1105E
E11254
UMLS CUI 2011AA
C0279694
MedDRA 14.1
10027861
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0237865
SNOMED CT 2011_0131
419511003
UMLS CUI 2011AA
C0026809
SNOMED CT 2011_0131
447482001
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0024730
SNOMED CT 2011_0131
387168006
LOINC Version 232
MTHU015736
For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
Beschreibung

For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0024301
SNOMED CT 2011_0131
277618009, 308121000
MedDRA 14.1
10061170
ICD-10-CM Version 2010
C82
ICD-9-CM Version 2011
202.0
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0024305
SNOMED CT 2011_0131
118601006
MedDRA 14.1
10029547
ICD-10-CM Version 2010
C85.9
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
UMLS CUI 2011AA
C0034619
For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
Beschreibung

For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2853945
ICD-10-CM Version 2010
C83
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
Beschreibung

History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C1282907
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
Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
Beschreibung

Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
Beschreibung

Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C2748291
MedDRA 14.1
10070353
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients, >/= 18 years of age
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
Item
CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
boolean
C0054946 (UMLS CUI 2011AA)
82753007 (SNOMED CT 2011_0131)
MTHU001655 (LOINC Version 232)
C0234227 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0024301 (UMLS CUI 2011AA)
277618009, 308121000 (SNOMED CT 2011_0131)
10061170 (MedDRA 14.1)
C82 (ICD-10-CM Version 2010)
202.0 (ICD-9-CM Version 2011)
C0349632 (UMLS CUI 2011AA)
128802003 (SNOMED CT 2011_0131)
10062113 (MedDRA 14.1)
C83.0 (ICD-10-CM Version 2010)
C0855139 (UMLS CUI 2011AA)
397349003, 277623009 (SNOMED CT 2011_0131)
10029460 (MedDRA 14.1)
C83.0 (ICD-10-CM Version 2010)
C0242647 (UMLS CUI 2011AA)
445269007 (SNOMED CT 2011_0131)
10021435 (MedDRA 14.1)
C88.4 (ICD-10-CM Version 2010)
Stage III or IV disease, or Stage II bulky disease, requiring treatment
Item
Stage III or IV disease, or Stage II bulky disease, requiring treatment
boolean
C0441771 (UMLS CUI 2011AA)
258224005 (SNOMED CT 2011_0131)
C0441772 (UMLS CUI 2011AA)
258228008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0441767 (UMLS CUI 2011AA)
258219007 (SNOMED CT 2011_0131)
C1511341 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
Item
At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
boolean
C1705052 (UMLS CUI 2011AA)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Item
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI 2011AA)
Adequate hematologic function
Item
Adequate hematologic function
boolean
C0221130 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Item
Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
boolean
C0280803 (UMLS CUI 2011AA)
307649006 (SNOMED CT 2011_0131)
10007953 (MedDRA 14.1)
200.5 (ICD-9-CM Version 2011)
C2213017 (UMLS CUI 2011AA)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1510411 (UMLS CUI 2011AA)
C0549177 (UMLS CUI 2011AA)
255509001 (SNOMED CT 2011_0131)
C0079731 (UMLS CUI 2011AA)
109979007 (SNOMED CT 2011_0131)
10003899 (MedDRA 14.1)
C0079744 (UMLS CUI 2011AA)
46732000 (SNOMED CT 2011_0131)
10012818 (MedDRA 14.1)
C83.3 (ICD-10-CM Version 2010)
Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
Item
Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
boolean
C2853827 (UMLS CUI 2011AA)
C82.4 (ICD-10-CM Version 2010)
C0855095 (UMLS CUI 2011AA)
302841002 (SNOMED CT 2011_0131)
10003908 (MedDRA 14.1)
C0024419 (UMLS CUI 2011AA)
190818004 (SNOMED CT 2011_0131)
10047801 (MedDRA 14.1)
C88.0 (ICD-10-CM Version 2010)
273.3 (ICD-9-CM Version 2011)
Ann Arbor Stage I disease
Item
Ann Arbor Stage I disease
boolean
C0474949 (UMLS CUI 2011AA)
254374001 (SNOMED CT 2011_0131)
C0441766 (UMLS CUI 2011AA)
258215001 (SNOMED CT 2011_0131)
MTHU035012 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
Item
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
boolean
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0002792 (UMLS CUI 2011AA)
39579001 (SNOMED CT 2011_0131)
10002199 (MedDRA 14.1)
T78.2 (ICD-10-CM Version 2010)
E11254 (CTCAE 1105E)
C0279694 (UMLS CUI 2011AA)
10027861 (MedDRA 14.1)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0237865 (UMLS CUI 2011AA)
419511003 (SNOMED CT 2011_0131)
C0026809 (UMLS CUI 2011AA)
447482001 (SNOMED CT 2011_0131)
C1514468 (UMLS CUI 2011AA)
C0024730 (UMLS CUI 2011AA)
387168006 (SNOMED CT 2011_0131)
MTHU015736 (LOINC Version 232)
For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
Item
For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
boolean
C0024301 (UMLS CUI 2011AA)
277618009, 308121000 (SNOMED CT 2011_0131)
10061170 (MedDRA 14.1)
C82 (ICD-10-CM Version 2010)
202.0 (ICD-9-CM Version 2011)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0024305 (UMLS CUI 2011AA)
118601006 (SNOMED CT 2011_0131)
10029547 (MedDRA 14.1)
C85.9 (ICD-10-CM Version 2010)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI 2011AA)
For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
Item
For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
boolean
C2853945 (UMLS CUI 2011AA)
C83 (ICD-10-CM Version 2010)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
Item
History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C1880198 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C1282907 (UMLS CUI 2011AA)
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)
Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
Item
Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
Item
Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C2748291 (UMLS CUI 2011AA)
10070353 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
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