ID
42074
Beschreibung
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
Stichworte
Versionen (2)
- 18.03.21 18.03.21 -
- 18.03.21 18.03.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. März 2021
DOI
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Lizenz
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
Beschreibung
Demographics (Enrollment)
Alias
- UMLS CUI-1
- C1704791
- UMLS CUI-2
- C1516879
Beschreibung
Patient Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Patient 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
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
For Coulter Use Only
Alias
- UMLS CUI-1
- C3846158
Beschreibung
Patient Enrollment Authorized by
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1555472
- UMLS CUI [1,2]
- C2700391
- UMLS CUI [1,3]
- C4041024
Beschreibung
Enrollment Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0679646
- UMLS CUI [1,3]
- C1516879
Beschreibung
Approved Dose
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205540
Beschreibung
Other approved dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0205540
- UMLS CUI [1,3]
- C0205394
Beschreibung
Adjust mCi dose for obesity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0028754
Beschreibung
Demographics (General Medical History)
Alias
- UMLS CUI-1
- C1704791
- UMLS CUI-2
- C0262926
Beschreibung
Date of Birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnic Origin
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Other Ethnic Origin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0015031
- UMLS CUI [1,2]
- C0205394
Beschreibung
Medical History Date
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0011008
Beschreibung
General Medical History
Alias
- UMLS CUI-1
- C0262926
Beschreibung
Diagnosis/Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0012634
Beschreibung
Date of Disease Onset
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Beschreibung
Disease Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschreibung
Prior Therapy
Alias
- UMLS CUI-1
- C1514463
Beschreibung
Please report all prior therapies for NHL (i.e., chemotherapy, immunotherapy, steroidal therapy).
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Therapy Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Therapy Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1531784
Beschreibung
Number of Therapy Cycles
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0750480
Beschreibung
Therapeutic Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1547647
Beschreibung
Duration of Response
Datentyp
integer
Maßeinheiten
- months
Alias
- UMLS CUI [1]
- C0237585
Beschreibung
Prior Radiation Therapy
Alias
- UMLS CUI-1
- C0279134
Beschreibung
Radiation Therapy Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0808070
Beschreibung
Radiation Therapy Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0806020
Beschreibung
Radiation Therapy Total Dose
Datentyp
integer
Maßeinheiten
- cGy
Alias
- UMLS CUI [1]
- C2919490
Beschreibung
Sites Treated
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0450429
Beschreibung
History of Lymphoma
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0262926
Beschreibung
Date of Diagnosis
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Stage at Diagnosis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C0011900
Beschreibung
Stage at Enrollment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1300072
- UMLS CUI [1,2]
- C1516879
Beschreibung
Lymphoma Cell Type
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0449475
Beschreibung
Cell Type
Datentyp
integer
Alias
- UMLS CUI [1]
- C0449475
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Specify other Cell-Type
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0449475
- UMLS CUI [1,2]
- C2348235
Beschreibung
Lymphoma Grade
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0441800
Beschreibung
Lymphoma Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0441800
Beschreibung
At diagnosis: only intermediate subtype of follicular large cell NHL
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
History of Lymphoma - Extranodal Involvement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C3899187
Beschreibung
History of Lymphoma
Alias
- UMLS CUI-1
- C0024299
- UMLS CUI-2
- C0262926
Beschreibung
History of Lymphoma - Extranodal Involvement at Enrollment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0024299
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2]
- C3899187
Beschreibung
Please check one method
Datentyp
integer
Alias
- UMLS CUI [1]
- C0054946
Beschreibung
Date tissue obtainted (CD20 Reactivity)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0475358
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0054946
Beschreibung
Date of assay (CD20 Reactivity)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005507
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0054946
Beschreibung
Does patient have evidence of bulky disease (> 500 gm)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1511341
- UMLS CUI [1,2]
- C0332120
Ähnliche Modelle
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])