ID
42075
Beschrijving
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin
Trefwoorden
Versies (2)
- 18-03-21 18-03-21 -
- 18-03-21 18-03-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 maart 2021
DOI
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Licentie
Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758
Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma
Beschrijving
Demographics (Enrollment)
Alias
- UMLS CUI-1
- C1704791
- UMLS CUI-2
- C1516879
Beschrijving
Patient Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Patient Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
For Coulter Use Only
Alias
- UMLS CUI-1
- C3846158
Beschrijving
Patient Enrollment Authorized by
Datatype
text
Alias
- UMLS CUI [1,1]
- C1555472
- UMLS CUI [1,2]
- C2700391
- UMLS CUI [1,3]
- C4041024
Beschrijving
Enrollment Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0679646
- UMLS CUI [1,3]
- C1516879
Beschrijving
Approved Dose
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205540
Beschrijving
Other approved dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205540
- UMLS CUI [1,3]
- C0205394
Beschrijving
Adjust mCi dose for obesity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0028754
Beschrijving
Demographics (General Medical History)
Alias
- UMLS CUI-1
- C1704791
- UMLS CUI-2
- C0262926
Beschrijving
Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnic Origin
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Other Ethnic Origin
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015031
- UMLS CUI [1,2]
- C0205394
Beschrijving
Medical History Date
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0011008
Beschrijving
General Medical History
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Diagnosis/Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0012634
Beschrijving
Date of Disease Onset
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschrijving
Disease Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Prior Therapy
Alias
- UMLS CUI-1
- C1514463
Beschrijving
Please report all prior therapies for NHL (i.e., chemotherapy, immunotherapy, steroidal therapy).
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Therapy Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
Therapy Stop Date
Datatype
date
Alias
- UMLS CUI [1]
- C1531784
Beschrijving
Number of Therapy Cycles
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750480
Beschrijving
Therapeutic Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1547647
Beschrijving
Duration of Response
Datatype
integer
Maateenheden
- months
Alias
- UMLS CUI [1]
- C0237585
Beschrijving
Prior Radiation Therapy
Alias
- UMLS CUI-1
- C0279134
Beschrijving
Radiation Therapy Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0808070
Beschrijving
Radiation Therapy Stop Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0806020
Beschrijving
Radiation Therapy Total Dose
Datatype
integer
Maateenheden
- cGy
Alias
- UMLS CUI [1]
- C2919490
Beschrijving
Sites Treated
Datatype
text
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0450429
Beschrijving
History of Lymphoma
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0262926
Beschrijving
Date of Diagnosis
Datatype
date
Alias
- UMLS CUI [1]
- C2316983
Beschrijving
Stage at Diagnosis
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0011900
Beschrijving
Stage at Enrollment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C1516879
Beschrijving
Lymphoma Cell Type
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0449475
Beschrijving
Cell Type
Datatype
integer
Alias
- UMLS CUI [1]
- C0449475
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Specify other Cell-Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C2348235
Beschrijving
Lymphoma Grade
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0441800
Beschrijving
Lymphoma Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0441800
Beschrijving
At diagnosis: only intermediate subtype of follicular large cell NHL
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
History of Lymphoma - Extranodal Involvement
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C3899187
Beschrijving
History of Lymphoma
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0262926
Beschrijving
History of Lymphoma - Extranodal Involvement at Enrollment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C3899187
Beschrijving
Please check one method
Datatype
integer
Alias
- UMLS CUI [1]
- C0054946
Beschrijving
Date tissue obtainted (CD20 Reactivity)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0054946
Beschrijving
Date of assay (CD20 Reactivity)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005507
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0054946
Beschrijving
Does patient have evidence of bulky disease (> 500 gm)?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1511341
- UMLS CUI [1,2]
- C0332120
Similar models
Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma
C0237753 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C1516879 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C2700391 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
C0679646 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
C0205540 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0028754 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C1547647 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C3899187 (UMLS CUI [2])
C0262926 (UMLS CUI [1,2])
C3899187 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0054946 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0054946 (UMLS CUI [2])
C0332120 (UMLS CUI [1,2])