ID
44907
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00989664
Nyckelord
Versioner (2)
- 2018-05-18 2018-05-18 - Halim Ugurlu
- 2022-04-06 2022-04-06 - Martin Dugas
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
6 april 2022
DOI
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Licens
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
Beskrivning
Laboratory Results Baseline
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beskrivning
Hematology Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0011008
Beskrivning
Lab Nr.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0022877
Beskrivning
WBC
Datatyp
float
Alias
- UMLS CUI [1]
- C0023508
Beskrivning
RBC
Datatyp
float
Alias
- UMLS CUI [1]
- C0014772
Beskrivning
Hemoglobin
Datatyp
float
Alias
- UMLS CUI [1]
- C0019046
Beskrivning
Hematocrit
Datatyp
float
Alias
- UMLS CUI [1]
- C0518014
Beskrivning
Platelets
Datatyp
float
Alias
- UMLS CUI [1]
- C0005821
Beskrivning
Neutrophils
Datatyp
float
Alias
- UMLS CUI [1]
- C0200633
Beskrivning
Lymphocytes
Datatyp
float
Alias
- UMLS CUI [1]
- C0200635
Beskrivning
Monocytes
Datatyp
float
Alias
- UMLS CUI [1]
- C0200637
Beskrivning
Eosinophils
Datatyp
float
Alias
- UMLS CUI [1]
- C0200638
Beskrivning
Basophils
Datatyp
float
Alias
- UMLS CUI [1]
- C0200641
Beskrivning
Other Differential
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0205394
Beskrivning
ANC-Absolute Neutrophile Count
Datatyp
float
Måttenheter
- 10³/mm³
Alias
- UMLS CUI [1]
- C0948762
Beskrivning
Laboratory Tests-Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Beskrivning
Chemistry Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005774
Beskrivning
Lab Nr.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0022877
Beskrivning
Sodium
Datatyp
float
Alias
- UMLS CUI [1]
- C0337443
Beskrivning
Potassium
Datatyp
float
Alias
- UMLS CUI [1]
- C0202194
Beskrivning
Chloride
Datatyp
float
Alias
- UMLS CUI [1]
- C0201952
Beskrivning
BUN
Datatyp
float
Alias
- UMLS CUI [1]
- C0005845
Beskrivning
Creatinine
Datatyp
float
Alias
- UMLS CUI [1]
- C0201976
Beskrivning
AST (SGOT)
Datatyp
float
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
ALT (SGPT)
Datatyp
float
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
Alkaline Phosphatase
Datatyp
float
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
LDH
Datatyp
float
Alias
- UMLS CUI [1]
- C0202113
Beskrivning
Total Bilirubin
Datatyp
float
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
TSH
Datatyp
float
Alias
- UMLS CUI [1]
- C0202230
Beskrivning
Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4
Datatyp
float
Alias
- UMLS CUI [1]
- C0428419
Beskrivning
Thyroid Tests may also be: T3U=T3 Uptake T3F=Free T3 T4T=Total T4
Datatyp
float
Alias
- UMLS CUI [1]
- C0202225
Beskrivning
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
N/A
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1272460
- UMLS CUI [1,2]
- C0032976
Beskrivning
Must be obtained within 7 days of study entry
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Beskrivning
Sample
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0032976
Beskrivning
Result
Datatyp
integer
Alias
- UMLS CUI [1]
- C0427777
Beskrivning
Beta-2 Microglobulin (Serum)
Alias
- UMLS CUI-1
- C0005149
Beskrivning
Infusion Record Dosimetric Dose - Day 0 and Day 7
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C2094191
Beskrivning
Baseline HAMA (human antimurine antibody)
Alias
- UMLS CUI-1
- C1291910
- UMLS CUI-2
- C1442488
Beskrivning
Dosimetric Dose
Alias
- UMLS CUI-1
- C2094191
Beskrivning
Time Started (cold)
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
Beskrivning
Time Finished (24 hour clock) (cold)
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
Beskrivning
Time Started (24 hour clock) (cold flush)
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
Beskrivning
Time Finished (24 hour clock) (cold flush)
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
Beskrivning
Time Started (24 hour clock) (hot)
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
Beskrivning
Time Finished (24 hour clock) (hot)
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
Beskrivning
Time Started (24 hour clock) (hot flush)
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
Beskrivning
Time Finished (24 hour clock) (hot flush)
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
Beskrivning
Anti-B1 Dose
Alias
- UMLS CUI-1
- C0768182
- UMLS CUI-2
- C3174092
Beskrivning
Anti-B1 Dose (cold dose)
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Beskrivning
Lot number of Anti-B1 (cold)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Beskrivning
Anti-B1 Dose (hot dose)
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Beskrivning
Lot number of Anti-B1 (hot)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Beskrivning
Iodine-131 Anti-B1 (prescribed)
Datatyp
text
Alias
- UMLS CUI [1]
- C0768182
Beskrivning
Lot Number (Nordion)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C3854006
Beskrivning
Infusion Rate
Alias
- UMLS CUI-1
- C2964135
Beskrivning
Infusion rate need to be adjusted?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C2826232
Beskrivning
If yes, was infusion rate
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C2826232
Beskrivning
If the infusion rate was adjusted, was it for (check all that apply)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C2826232
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Time (24 hr)
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
BP
Datatyp
text
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Pulse
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Temp
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Adverse Experiences
Alias
- UMLS CUI-1
- C0877248
Beskrivning
If yes, please record on AE page
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
(Note; only Day 7) Compliance with SSKI, Lugol`s solution or Potassium iodide
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0032831
- UMLS CUI [1,3]
- C0065234
Beskrivning
(Note; only Day 7) If No to previous question please explain
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0681841
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
C0600091 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0005774 (UMLS CUI-2)
C0005774 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0005149 (UMLS CUI [1,3])
C0005149 (UMLS CUI [1,2])
C2094191 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1442488 (UMLS CUI-2)
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0768182 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
C0032831 (UMLS CUI [1,2])
C0065234 (UMLS CUI [1,3])
C0681841 (UMLS CUI [1,2])
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