ID
42089
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 (1)
- 01-04-21 01-04-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 april 2021
DOI
Voor een aanvraag inloggen.
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
Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response
Beschrijving
Physical Examination (Follow-Up)
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C1522577
Beschrijving
Please check the appropriate visit week
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0439230
Beschrijving
Specify other week
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Does the patient currently have evidence of
Datatype
text
Alias
- UMLS CUI [1,1]
- C1706867
- UMLS CUI [1,2]
- C0521116
Beschrijving
Current
Datatype
integer
Alias
- UMLS CUI [1]
- C1706867
Beschrijving
Date of physical examination
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Karnofsky Status
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0206065
Beschrijving
Respirations
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0035203
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Pulse
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Physical Examination (Follow-Up)
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C1522577
Beschrijving
Organ/ System
Datatype
integer
Alias
- UMLS CUI [1]
- C0678852
Beschrijving
Result
Datatype
integer
Alias
- UMLS CUI [1]
- C1274040
Beschrijving
If abnormal, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Beschrijving
Laboratory Results - Hematology/ Chemistry (Follow-Up)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-3
- C0018943
- UMLS CUI-5
- C0008000
- UMLS CUI-7
- C1522577
Beschrijving
Please check the appropriate visit week
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0439230
Beschrijving
Specify other week
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Laboratory Results (Follow-Up) - Hematology
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0018943
- UMLS CUI-3
- C1522577
Beschrijving
Hematology Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beschrijving
Performed at primary lab listed on 1572? (Hematology)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0018943
Beschrijving
Laboratory Results (Follow-Up) - Hematology
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0018943
- UMLS CUI-3
- C1522577
Beschrijving
Laboratory Test (Hematology)
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Laboratory Test Result (Hematology)
Datatype
float
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0587081
Beschrijving
Laboratory Results (Follow-Up) - Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C1522577
Beschrijving
Chemistry Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0011008
Beschrijving
Performed at primary lab listed on 1572? (Chemistry)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
Beschrijving
Laboratory Results (Follow-Up) - Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C1522577
Beschrijving
Laboratory Test (Chemistry)
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
Laboratory Test Result (Chemistry)
Datatype
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0008000
Beschrijving
Post-Treatment Response (Follow -Up)
Alias
- UMLS CUI-1
- C0521982
Beschrijving
Please check the appropriate visit week
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0439230
Beschrijving
Specify other week
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0040405
- UMLS CUI-3
- C0011923
- UMLS CUI-4
- C1274040
- UMLS CUI-5
- C1522577
Beschrijving
Organ/System
Datatype
integer
Alias
- UMLS CUI [1]
- C0678852
Beschrijving
Imaging Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0011008
Beschrijving
Imaging Not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1272696
Beschrijving
Radiological Imaging
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1275506
Beschrijving
Specify other radiological imaging
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Radiological Imaging Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Beschrijving
Specify abnormal Imaging result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C2348235
Beschrijving
Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0699749
- UMLS CUI-3
- C0005954
- UMLS CUI-4
- C1522577
Beschrijving
Date of biopsy
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
Beschrijving
Bone Marrow Biopsy not done/not indicated
Datatype
integer
Alias
- UMLS CUI [1]
- C0005954
- UMLS CUI [2]
- C1272696
- UMLS CUI [3]
- C3146298
Beschrijving
Marrow cellularity
Datatype
integer
Alias
- UMLS CUI [1]
- C1561532
Beschrijving
Tumor involvement
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1314939
Beschrijving
Tumor involvement
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1314939
Beschrijving
Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1513041
- UMLS CUI-4
- C1522577
Beschrijving
Site
Datatype
text
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
Method of Determination
Datatype
text
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Date of Measurement
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242485
Beschrijving
Tumor Measurments - Diameter 1
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1301886
Beschrijving
Tumor Measurments - Diameter 2
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1301886
Beschrijving
Tumor Measurment Result
Datatype
float
Maateenheden
- cm^2
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1274040
Beschrijving
Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1522577
Beschrijving
Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1334988
- UMLS CUI-4
- C1522577
Beschrijving
Site
Datatype
text
Alias
- UMLS CUI [1]
- C1515974
Beschrijving
Method of Determination
Datatype
text
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Date of Measurement
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242485
Beschrijving
Check one
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Post-Treatment Response (Follow-Up) - Response
Alias
- UMLS CUI-1
- C0521982
- UMLS CUI-2
- C1522577
Beschrijving
Response
Datatype
integer
Alias
- UMLS CUI [1]
- C0521982
Beschrijving
Date of Response Evaluation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0011008
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Signature of Investigator
Alias
- UMLS CUI-1
- C2346576
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C0008000 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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C2348235 (UMLS CUI [3])
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C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0699749 (UMLS CUI-2)
C0005954 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])
C1272696 (UMLS CUI [2])
C3146298 (UMLS CUI [3])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI-2)
C1513041 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0242485 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0024299 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C1334988 (UMLS CUI [1,2])
C0024299 (UMLS CUI-2)
C1334988 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0242485 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])