ID
42079
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 (3)
- 3/23/21 3/23/21 -
- 3/23/21 3/23/21 -
- 3/25/21 3/25/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 25, 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
Baseline - Physical Examination; Laboratory Results; Disease Staging
Description
Physical Examination (Baseline)
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C1442488
Description
Does the patient currently have evidence of
Data type
text
Alias
- UMLS CUI [1,1]
- C1706867
- UMLS CUI [1,2]
- C0521116
Description
Current
Data type
integer
Alias
- UMLS CUI [1]
- C1706867
Description
Date of physical examination
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Karnofsky Status
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0206065
Description
Respirations
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0035203
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Pulse
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Physical Examination (Baseline)
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C1442488
Description
Organ/ System
Data type
integer
Alias
- UMLS CUI [1]
- C0678852
Description
Result
Data type
integer
Alias
- UMLS CUI [1]
- C1274040
Description
If abnormal, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2348235
Description
Laboratory Results (Baseline) - Hematology
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0018943
Description
Hematology Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Description
Performed at primary lab listed on 1572? (Hematology)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0018943
Description
Laboratory Results (Baseline) - Hematology
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0018943
Description
Laboratory Test (Hematology)
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Laboratory Test Result (Hematology)
Data type
float
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0587081
Description
Laboratory Results (Baseline) - Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0008000
Description
Chemistry Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0011008
Description
Performed at primary lab listed on 1572? (Chemistry)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
Description
Laboratory Results (Baseline) - Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C1442488
- UMLS CUI-3
- C0008000
Description
Laboratory Test (Chemistry)
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Beta-2 Microglobulin Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0005149
- UMLS CUI [1,2]
- C0011008
Description
HAMA Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1291910
- UMLS CUI [1,2]
- C0011008
Description
Laboratory Test Result (Chemistry)
Data type
float
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0008000
Description
HAMA Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C1291910
- UMLS CUI [1,2]
- C1274040
Description
Pregnancy Test (Baseline)
Alias
- UMLS CUI-1
- C0032976
- UMLS CUI-2
- C1442488
Description
Pregnancy Test Result
Data type
integer
Alias
- UMLS CUI [1]
- C0427777
Description
Pregnancy Test Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
Pregnancy Test Method
Data type
integer
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0871511
Description
Disease Staging - CT or other Radiological Imaging Results (Baseline)
Alias
- UMLS CUI-1
- C0699749
- UMLS CUI-2
- C0040405
- UMLS CUI-3
- C0011923
- UMLS CUI-4
- C1274040
- UMLS CUI-5
- C1442488
Description
Organ/System
Data type
integer
Alias
- UMLS CUI [1]
- C0678852
Description
Imaging Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0011008
Description
Imaging Not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1272696
Description
Radiological Imaging
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1275506
Description
Specify other radiological imaging
Data type
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Description
Radiological Imaging Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1274040
Description
Specify abnormal Imaging result
Data type
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C2826279
- UMLS CUI [1,3]
- C2348235
Description
Disease Staging - Bone Marrow Biopsy (Baseline)
Alias
- UMLS CUI-1
- C0699749
- UMLS CUI-2
- C0005954
- UMLS CUI-3
- C1442488
Description
Date of biopsy
Data type
date
Alias
- UMLS CUI [1,1]
- C0005558
- UMLS CUI [1,2]
- C0011008
Description
Marrow cellularity
Data type
integer
Alias
- UMLS CUI [1]
- C1561532
Description
Tumor involvement
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1314939
Description
Tumor involvement
Data type
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1314939
Description
Disease Staging - Measurable Lymphoma Disease (Baseline)
Alias
- UMLS CUI-1
- C0699749
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1513041
- UMLS CUI-4
- C1442488
Description
Site
Data type
text
Alias
- UMLS CUI [1]
- C1515974
Description
Method of Determination
Data type
text
Alias
- UMLS CUI [1]
- C2911685
Description
Date of Measurement
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242485
Description
Tumor Measurments - Diameter 1
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1301886
Description
Tumor Measurments - Diameter 2
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1301886
Description
Tumor Measurment Result
Data type
float
Measurement units
- cm^2
Alias
- UMLS CUI [1,1]
- C0475440
- UMLS CUI [1,2]
- C1274040
Description
Disease Staging - Non-Measurable Lymphoma Disease (Baseline)
Alias
- UMLS CUI-1
- C0699749
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1334988
- UMLS CUI-4
- C1442488
Description
Disease Staging - Non-Measurable Lymphoma Disease (Baseline)
Alias
- UMLS CUI-1
- C0699749
- UMLS CUI-2
- C0024299
- UMLS CUI-3
- C1334988
- UMLS CUI-4
- C1442488
Description
Signature of Investigator
Alias
- UMLS CUI-1
- C2346576
Similar models
Baseline - Physical Examination; Laboratory Results; Disease Staging
C0237753 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0521116 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1442488 (UMLS CUI-2)
C0018943 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0018943 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0018943 (UMLS CUI-3)
C0587081 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,2])
C0040405 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
C1442488 (UMLS CUI-5)
C0011008 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1274040 (UMLS CUI [1,2])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0005954 (UMLS CUI-2)
C1442488 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI-2)
C1513041 (UMLS CUI-3)
C1442488 (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)
C1334988 (UMLS CUI-3)
C1442488 (UMLS CUI-4)
C1334988 (UMLS CUI [1,2])
C0024299 (UMLS CUI-2)
C1334988 (UMLS CUI-3)
C1442488 (UMLS CUI-4)
C0242485 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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