ID
30221
Beschreibung
https://clinicaltrials.gov/show/NCT00989664 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin
Link
https://clinicaltrials.gov/show/NCT00989664
Stichworte
Versionen (2)
- 30.04.18 30.04.18 -
- 22.05.18 22.05.18 -
Rechteinhaber
GlaxoSmithKline (GSK)
Hochgeladen am
22. Mai 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664
Patient Enrollment, Demographics and Eligibility check
- StudyEvent: ODM
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Non-Hodgkins B-cell lymphoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024305
Beschreibung
Date of diagnosis
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
IWF lymphoma histology
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0019638
- UMLS CUI [1,2]
- C0024299
Beschreibung
Transformation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1510411
Beschreibung
Transformation
Datentyp
integer
Alias
- UMLS CUI [1]
- C1510411
Beschreibung
Date of transformation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1510411
Beschreibung
Sites of disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027653
Beschreibung
CD20 Positivity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0054946
- UMLS CUI [1,2]
- C0024299
Beschreibung
Rituximab therapy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0393022
Beschreibung
Number of rituximab doses
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0393022
Beschreibung
Effect of rituximab therapy
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0393022
Beschreibung
Karnofsky Scale and life expectancy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0206065
- UMLS CUI [1,2]
- C0023671
Beschreibung
Granulocyte and platelet count
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0857490
- UMLS CUI [1,2]
- C0005821
Beschreibung
Date of blood sample
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschreibung
ANC
Datentyp
integer
Maßeinheiten
- mm³
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
Platelet count
Datentyp
integer
Maßeinheiten
- mm^3
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Renal and hepatic function
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232804
- UMLS CUI [1,2]
- C0232741
Beschreibung
Date of laboratory tests
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0022885
Beschreibung
Creatinine
Datentyp
float
Maßeinheiten
- mg/dL; ULN
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
Bilirubin
Datentyp
float
Maßeinheiten
- mg/dL; ULN
Alias
- UMLS CUI [1]
- C1278039
Beschreibung
AST
Datentyp
float
Maßeinheiten
- IU/L; ULN
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
ALT
Datentyp
float
Maßeinheiten
- IU/L; ULN
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
Bi-dimensional measurable disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1513041
- UMLS CUI [1,2]
- C1705052
Beschreibung
Age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Date of informed consent
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Bone marrow involved in Lymphoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517677
- UMLS CUI [2]
- C0005954
Beschreibung
Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0021081
- UMLS CUI [4]
- C0199974
Beschreibung
Stem cell transplant and chemo/radiotherapy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3874407
- UMLS CUI [1,2]
- C0279134
Beschreibung
Obstructive hydronephrosis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020295
- UMLS CUI [1,2]
- C0549186
Beschreibung
Active infection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0205177
Beschreibung
NYHA heart disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018799
- UMLS CUI [1,2]
- C1275491
Beschreibung
Cancer history
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0006826
Beschreibung
HIV infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019693
Beschreibung
Brain or leptomeningeal metastases
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0220650
- UMLS CUI [1,2]
- C1704231
Beschreibung
Pregnancy or nursing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beschreibung
Allergic reactions to iodine
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0021968
Beschreibung
Radioimmunotherapy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085101
Beschreibung
Progressive disease in field of irradiation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2169147
Beschreibung
HAMA positivity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3541258
Beschreibung
Anti-cancer drugs or biologics
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0920425
Beschreibung
Administration
Alias
- UMLS CUI-1
- C1320722
Beschreibung
Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Patient Enrollment Authorized
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1555472
- UMLS CUI [1,2]
- C2700391
- UMLS CUI [1,3]
- C4041024
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0680281
Beschreibung
Approved dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205540
Beschreibung
Adjust mCi dose
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1707811
Ähnliche Modelle
Patient Enrollment, Demographics and Eligibility check
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,2])
C1510411 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,3])
C0393022 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,2])
C0005954 (UMLS CUI [2])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
C0279134 (UMLS CUI [1,2])
C0549186 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C1704231 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0021968 (UMLS CUI [1,2])
C2169147 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2700391 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
C0680281 (UMLS CUI [1,2])
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