Informatie:
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ID
44907
Beschrijving
https://clinicaltrials.gov/show/NCT00989664 Eligibility check Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin
Link
https://clinicaltrials.gov/show/NCT00989664
Trefwoorden
Versies (2)
- 18/05/18 18/05/18 - Halim Ugurlu
- 06/04/22 06/04/22 - Martin Dugas
Houder van rechten
GlaxoSmithKline (GSK)
Geüploaded op
6 aprile 2022
DOI
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Licentie
Creative Commons BY-NC 4.0
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Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
- StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
Similar models
Laboratory Results Baseline, Infusion Record Therapy Dose - Day 0 and Day 7
- StudyEvent: Multicenter Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site Number
Item
Site Number:
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Laboratory Results Baseline
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Hematology Date
Item
Hematology Date
date
C0474523 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Other Differential
Item
Other Differential
text
C0022885 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
ANC-Absolute Neutrophile Count
Item
Absolute Neutrophile Count-ANC (10³/mm³)
float
C0948762 (UMLS CUI [1])
Item Group
Laboratory Tests-Blood Chemistry
C1254595 (UMLS CUI-1)
C0005774 (UMLS CUI-2)
C0005774 (UMLS CUI-2)
Chemistry Date
Item
Chemistry Date
date
C0011008 (UMLS CUI [1,1])
C0005774 (UMLS CUI [1,2])
C0005774 (UMLS CUI [1,2])
Lab Nr.
Item
Lab # (Worksheet B)
text
C1300638 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
TSH
Item
TSH
float
C0202230 (UMLS CUI [1])
Total T3
Item
Total T3
float
C0428419 (UMLS CUI [1])
Free T4
Item
Free T4
float
C0202225 (UMLS CUI [1])
N/A
Item
N/A
boolean
C1272460 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
CL Item
Urine (1)
CL Item
Serum (2)
CL Item
Positive (1)
CL Item
Negative (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,3])
Result
Item
Result
text
C1274040 (UMLS CUI [1,1])
C0005149 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,2])
Item Group
Infusion Record Dosimetric Dose - Day 0 and Day 7
C0574032 (UMLS CUI-1)
C2094191 (UMLS CUI-2)
C2094191 (UMLS CUI-2)
Date Administered
Item
Date Administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Baseline HAMA (human antimurine antibody)
C1291910 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI-2)
Baseline HAMA date
Item
Baseline HAMA date
date
C1291910 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Baseline HAMA Result
integer
C1442488 (UMLS CUI [1,1])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
Time Started (cold)
Item
Time Started (24 hour clock) (cold)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold)
Item
Time Finished (24 hour clock) (cold)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (cold flush)
Item
Time Started (24 hour clock) (cold flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (cold flush)
Item
Time Finished (24 hour clock) (cold flush)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot)
Item
Time Started (24 hour clock) (hot)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot)
Item
Time Finished (24 hour clock) (hot)
time
C1522314 (UMLS CUI [1])
Time Started (24 hour clock) (hot flush)
Item
Time Started (24 hour clock) (hot flush)
time
C1301880 (UMLS CUI [1])
Time Finished (24 hour clock) (hot flush)
Item
Time Finished (24 hour clock) (hot flush)
time
C1522314 (UMLS CUI [1])
Anti-B1 Dose (cold dose)
Item
Anti-B1 Dose (cold dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1 (cold)
Item
Lot number of Anti-B1 (cold)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
Anti-B1 Dose (hot dose)
Item
Anti-B1 Dose (hot dose)
float
C0768182 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Lot number of Anti-B1 (hot)
Item
Lot number of Anti-B1 (hot)
text
C1115660 (UMLS CUI [1,1])
C0768182 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
Iodine-131 Anti-B1 (prescribed)
Item
Iodine-131 Anti-B1 (prescribed)
text
C0768182 (UMLS CUI [1])
Lot Number (Nordion)
Item
Lot Number (Nordion)
text
C1115660 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Infusion rate need to be adjusted?
Item
Did infusion rate need to be adjusted?
boolean
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
Item
If yes, was infusion rate
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
CL Item
Decreased by 1/2 (1)
CL Item
discontinued (2)
CL Item
other (3)
Item
If the infusion rate was adjusted, was it for (check all that apply)
integer
C2964135 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
Code List
If the infusion rate was adjusted, was it for (check all that apply)
CL Item
low SBP (1)
CL Item
rigors (2)
CL Item
fever (3)
CL Item
mucosal congestion/edema (4)
CL Item
other (5)
Time (24 hr)
Item
Time (24 hr)
time
C0040223 (UMLS CUI [1])
BP
Item
Blood Pressure (mmhg)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temp
Item
Temp. (C)
float
C0005903 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Did the patient have any adverse experiences?
Item
Did the patient have any adverse experiences? (If yes, please record on AE page)
boolean
C0877248 (UMLS CUI [1])
(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide
Item
(Note; only Day 7) Was patient compliant with SSKI, Lugol`s solution or Potassium iodide as described in protocol?
boolean
C1321605 (UMLS CUI [1,1])
C0032831 (UMLS CUI [1,2])
C0065234 (UMLS CUI [1,3])
C0032831 (UMLS CUI [1,2])
C0065234 (UMLS CUI [1,3])
(Note; only Day 7) If No to previous question please explain
Item
(Note; only Day 7) If No to previous question please explain
text
C0947611 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,2])
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