ID
42093
Description
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
Keywords
Versions (2)
- 4/7/21 4/7/21 -
- 4/7/21 4/7/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 7, 2021
DOI
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License
Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758
Long-Term Follow-Up for Survival and Disease Status
- StudyEvent: ODM
Description
Long-Term Follow-Up for Survival and Disease Status
Alias
- UMLS CUI-1
- C1517942
- UMLS CUI-2
- C1148433
- UMLS CUI-3
- C0699749
Description
Patient status
Data type
integer
Alias
- UMLS CUI [1]
- C0449437
Description
How was contact made?
Data type
integer
Alias
- UMLS CUI [1]
- C1705415
Description
Specify other contact
Data type
text
Alias
- UMLS CUI [1,1]
- C1705415
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
If Yes, please complete Response Assessment formsif applicable.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0521982
- UMLS CUI [1,3]
- C0549178
Description
Since the time the last LTFU was completed, has any of the following occured?
Alias
- UMLS CUI-1
- C1517942
- UMLS CUI-2
- C3872643
Description
Subsequent NHL Therapy since last LTFU
Alias
- UMLS CUI-1
- C0024305
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C3872643
Description
Subsequent NHL Therapy since last LTFU
Data type
text
Alias
- UMLS CUI [1]
- C0024305
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C3872643
Description
NHL Therapy Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0024305
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0808070
Description
NHL Therapy Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0024305
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0806020
Description
NHL Therapy total number of Cycles
Data type
integer
Alias
- UMLS CUI [1,1]
- C0024305
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [2,1]
- C1511572
- UMLS CUI [2,2]
- C0750480
Description
Myelodysplasia
Alias
- UMLS CUI-1
- C0026985
Description
Has the patient had a documented new diagnosis of myelodysplasia?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C0011900
Description
(Complete both AE & SAE CRFs)
Data type
date
Alias
- UMLS CUI [1,1]
- C0026985
- UMLS CUI [1,2]
- C2316983
Description
(Complete both AE & SAE CRFs)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C0011900
Description
If yes, date of diagnosis (AML)
Data type
date
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C2316983
Description
Another malignancy
Alias
- UMLS CUI-1
- C0006826
Description
(Complete both AE & SAE CRFs)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0011900
Description
If yes, date of diagnosis (another malignancy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C2316983
Description
Type of malignancy
Data type
text
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C0332307
Description
Thyroid medication
Alias
- UMLS CUI-1
- C0040128
- UMLS CUI-2
- C0013227
Description
TSH Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0202230
- UMLS CUI [1,2]
- C0011008
Description
TSH Result
Data type
float
Measurement units
- uIU/mL
Alias
- UMLS CUI [1,1]
- C0202230
- UMLS CUI [1,2]
- C1274040
Description
TSH not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202230
- UMLS CUI [1,2]
- C1272696
Description
(If yes, complete both AE & Concomitant Medication CRFs)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2242640
- UMLS CUI [1,2]
- C1517942
- UMLS CUI [1,3]
- C3872643
Description
Start date (thyroid medication)
Data type
date
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0808070
Description
If Yes, drug name (thyroid medication)
Data type
text
Alias
- UMLS CUI [1,1]
- C0040128
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C2360065
Description
HAMA
Alias
- UMLS CUI-1
- C1291910
Description
If yes, attach copy of lab report to CRF
Data type
text
Alias
- UMLS CUI [1,1]
- C1291910
- UMLS CUI [1,2]
- C1517942
- UMLS CUI [1,3]
- C3872643
Description
If yes, enter accesssion Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1514821
- UMLS CUI [1,2]
- C0237753
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Long-Term Follow-Up for Survival and Disease Status
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C1148433 (UMLS CUI-2)
C0699749 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0521982 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C3872643 (UMLS CUI-2)
C1706712 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C3872643 (UMLS CUI-3)
C0087111 (UMLS CUI [2])
C3872643 (UMLS CUI [3])
C0087111 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1511572 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0011900 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1517942 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C1517942 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])