Information:
Fel:
ID
42089
Beskrivning
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
Nyckelord
Versioner (1)
- 2021-04-01 2021-04-01 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
1 april 2021
DOI
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Licens
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
Similar models
Follow-Up - Physical Examination; Laboratory Results; Post-Treatment Response
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site Number
Item
Site Number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Series Page
Item
Series Page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1704732 (UMLS CUI [1,2])
Item Group
Physical Examination (Follow-Up)
C0031809 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Item
Please check the appropriate visit week
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1.5 years) (2)
CL Item
Week 104 (2 years) (3)
CL Item
Other Week, specify (4)
Specify other week
Item
Specify other week
integer
C0439230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Does the patient currently have evidence of "B" symptoms?
text
C1706867 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Code List
Does the patient currently have evidence of "B" symptoms?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Done (ND)
CL Item
Night sweats (1)
CL Item
Intermittent fevers (2)
CL Item
Weight loss (3)
Date of physical examination
Item
Date of physical examination
date
C2826643 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Karnofsky Status
Item
Karnofsky Status
integer
C0206065 (UMLS CUI [1])
Respirations
Item
Respirations
integer
C0035203 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Physical Examination (Follow-Up)
C0031809 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
CL Item
General Appearance (1)
CL Item
Skin (2)
CL Item
HEENT (3)
CL Item
Neck (4)
CL Item
Lymph Nodes (5)
CL Item
Lungs (6)
CL Item
Heart (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Abdomen (10)
CL Item
Musculoskeletal (11)
CL Item
Other (12)
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
If abnormal, specify
Item
If abnormal, specify
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Laboratory Results - Hematology/ Chemistry (Follow-Up)
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-3)
C0008000 (UMLS CUI-5)
C1522577 (UMLS CUI-7)
C0018943 (UMLS CUI-3)
C0008000 (UMLS CUI-5)
C1522577 (UMLS CUI-7)
Item
Please check the appropriate visit week
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1.5 years) (2)
CL Item
Week 104 (2 years) (3)
CL Item
Other week, specify (4)
Specify other week
Item
Specify other week
text
C0439230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Laboratory Results (Follow-Up) - Hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0018943 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Performed at primary lab listed on 1572? (Hematology)
Item
Performed at primary lab listed on 1572? (Hematology)
boolean
C0022885 (UMLS CUI [1,1])
C0018943 (UMLS CUI [1,2])
C0018943 (UMLS CUI [1,2])
Item Group
Laboratory Results (Follow-Up) - Hematology
C1254595 (UMLS CUI-1)
C0018943 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0018943 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
CL Item
WBC (10^3/mm^3) (1)
CL Item
RBC (10^6/mm^3) (2)
CL Item
Hemoglobin (g/dL) (3)
CL Item
Hematocrit (%) (4)
CL Item
Platelet Count (10^3/mm^3) (5)
CL Item
Neutrophils (10^3/mm^3) (segs + bands) (6)
CL Item
Lymphocytes (10^3/mm^3) (7)
CL Item
Monocytes (10^3/mm^3) (8)
CL Item
Eosinophils (10^3/mm^3) (9)
CL Item
Basophils (10^3/mm^3) (10)
CL Item
Other Differential (10^3/mm^3) (11)
Laboratory Test Result (Hematology)
Item
Laboratory Test Result (Hematology)
float
C0018941 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item Group
Laboratory Results (Follow-Up) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0008000 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Chemistry Date
Item
Chemistry Date
date
C0008000 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Performed at primary lab listed on 1572? (Chemistry)
Item
Performed at primary lab listed on 1572? (Chemistry)
boolean
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Item Group
Laboratory Results (Follow-Up) - Chemistry
C1254595 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0008000 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
CL Item
Sodium (mEq/L) (1)
CL Item
Potassium (mEq/L) (2)
CL Item
Chloride (mEq/L) (3)
CL Item
BUN (mg/dL) (4)
CL Item
Creatinine (mg/dL) (5)
CL Item
AST/GOT (IU/L) (6)
CL Item
Alkaline Phosphatase (IU/L) (7)
CL Item
LDH (IU/L) (8)
CL Item
Total Bilirubin (mg/dL) (9)
CL Item
TSH (uU/mL) (10)
CL Item
Total T3 (ng/dL) (11)
CL Item
Free T4 (ug/dL) (12)
Laboratory Test Result (Chemistry)
Item
Laboratory Test Result (Chemistry)
float
C0587081 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
Item Group
Post-Treatment Response (Follow -Up)
C0521982 (UMLS CUI-1)
Item
Please check the appropriate visit week
integer
C0545082 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,2])
CL Item
Week 52 (1 year) (1)
CL Item
Week 78 (1.5 years) (2)
CL Item
Week 104 (2 years) (3)
CL Item
Other Week, specify (4)
Specify other week
Item
Specify other week
integer
C0439230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Post-Treatment Response (Follow-Up) - CT or other Radiological Imaging Results
C0521982 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
C1522577 (UMLS CUI-5)
C0040405 (UMLS CUI-2)
C0011923 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
C1522577 (UMLS CUI-5)
CL Item
Head/Neck (1)
CL Item
Chest (2)
CL Item
Abdomen (3)
CL Item
Pelvis (4)
CL Item
Other (5)
Imaging Date
Item
Imaging Date
date
C0011923 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Not Done (1)
Item
Radiological Imaging
integer
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
CL Item
CT (1)
CL Item
MRI (2)
CL Item
X-ray (3)
CL Item
Other (4)
Specify other radiological imaging
Item
Specify other radiological imaging
text
C0011923 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Radiological Imaging Result
integer
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (specify) (2)
Specify abnormal Imaging result
Item
Specify abnormal Imaging result
text
C0011923 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2826279 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Post-Treatment Response (Follow-Up) - Bone Marrow Biopsy
C0521982 (UMLS CUI-1)
C0699749 (UMLS CUI-2)
C0005954 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0699749 (UMLS CUI-2)
C0005954 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Date of biopsy
Item
Date of biopsy
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Bone Marrow Biopsy not done/not indicated
integer
C0005954 (UMLS CUI [1])
C1272696 (UMLS CUI [2])
C3146298 (UMLS CUI [3])
C1272696 (UMLS CUI [2])
C3146298 (UMLS CUI [3])
CL Item
Not done (1)
CL Item
Not indicated (patient not in CCR or CR) (2)
CL Item
Normal (1)
CL Item
Hypocellular (2)
CL Item
Hypercellular (3)
Tumor involvement
Item
Tumor involvement
float
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
Item
Tumor involvement
integer
C0006826 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
CL Item
Unilateral (1)
CL Item
Bilateral (2)
Item Group
Post-Treatment Response (Follow-Up) - Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
C1513041 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0024299 (UMLS CUI-2)
C1513041 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date of Measurement
Item
Date of Measurement
date
C0011008 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,2])
Tumor Measurments - Diameter 1
Item
Tumor Measurments - Diameter 1
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
Tumor Measurments - Diameter 2
Item
Tumor Measurments - Diameter 2
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
Tumor Measurment Result
Item
Tumor Measurment Result
float
C0475440 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
Item Group
Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0024299 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Item
Non-Measurable Lymphoma Disease - Check if None
integer
C0024299 (UMLS CUI [1,1])
C1334988 (UMLS CUI [1,2])
C1334988 (UMLS CUI [1,2])
Code List
Non-Measurable Lymphoma Disease - Check if None
CL Item
None (1)
Item Group
Post-Treatment Response (Follow-Up) - Non-Measurable Lymphoma Disease
C0521982 (UMLS CUI-1)
C0024299 (UMLS CUI-2)
C1334988 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C0024299 (UMLS CUI-2)
C1334988 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
Site
Item
Site
text
C1515974 (UMLS CUI [1])
Method of Determination
Item
Method of Determination
text
C2911685 (UMLS CUI [1])
Date of Measurement
Item
Date of Measurement
date
C0011008 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,2])
CL Item
New (1)
CL Item
Increased (2)
CL Item
Stable (3)
CL Item
Decreased (4)
Item Group
Post-Treatment Response (Follow-Up) - Response
C0521982 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
CL Item
PD (1)
CL Item
SD (2)
CL Item
PR (3)
CL Item
CCR (4)
CL Item
CR (5)
Date of Response Evaluation
Item
Date of Response Evaluation
date
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Signature of Investigator Date
Item
Signature of Investigator Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])