ID
42077
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 (1)
- 3/23/21 3/23/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 23, 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
Infusion Record
- StudyEvent: ODM
Description
Infusion Record - Dosimetric Dose
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C2094191
Description
Date administered (Dosimetric Dose)
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C4019308
Description
Time Started (Dosimetric Dose) - Cold
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C4019308
- UMLS CUI [3]
- C0009264
Description
Time Started (Dosimetric Dose) - Cold Flush
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C4019308
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C0009264
Description
Time Started (Dosimetric Dose) - Hot
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C4019308
- UMLS CUI [3]
- C2350229
Description
Time Started (Dosimetric Dose) - Hot Flush
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C4019308
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C2350229
Description
Time Finished (Dosimetric Dose) - Cold
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C4019308
- UMLS CUI [3]
- C0009264
Description
Time Finished (Dosimetric Dose) - Cold Flush
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C4019308
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C0009264
Description
Time Finished (Dosimetric Dose) - Hot
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C4019308
- UMLS CUI [3]
- C2350229
Description
Time Finished (Dosimetric Dose) - Hot Flush
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C4019308
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C2350229
Description
Anti-B1 dose (cold dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0768182
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C0009264
Description
Lot number of Anti-B1
Data type
text
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C1115660
Description
Anti-B1 dose (hot dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0768182
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C2350229
Description
Lot number of Anti-B1
Data type
text
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C1115660
Description
Iodine-131 Anti-B1 (prescripted)
Data type
float
Measurement units
- mCi
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0278329
Description
Lot number (Nordion)
Data type
text
Alias
- UMLS CUI [1]
- C1115660
Description
Did infusion rate need to be adjusted?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C2826232
Description
If yes, specify adjustment of infusion rate
Data type
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C2348235
Description
Specify other adjustment of infusion rate
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Check all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C2348235
Description
Specify other reason for adjustment
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Description
If yes, please record on AE page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Infusion Record - Vital Signs (Dosimetric Dose)
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C0518766
- UMLS CUI-3
- C2094191
Description
24 hr
Data type
time
Alias
- UMLS CUI [1]
- C0040223
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
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Infusion Record - Therapeutic Dose
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0302350
Description
Date administered (Therapeutic Dose)
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
Description
Time Started (Therapeutic Dose) - Cold
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3]
- C0009264
Description
Time Started (Therapeutic Dose) - Cold Flush
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C0009264
Description
Time Started (Therapeutic Dose) - Hot
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3]
- C2350229
Description
Time Started (Therapeutic Dose) - Hot Flush
Data type
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C2350229
Description
Time Finished (Therapeutic Dose) - Cold
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3]
- C0009264
Description
Time Finished (Therapeutic Dose) - Cold Flush
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C0009264
Description
Time Finished (Therapeutic Dose) - Hot
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3]
- C2350229
Description
Time Finished (Therapeutic Dose) - Hot Flush
Data type
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0302350
- UMLS CUI [3,1]
- C1696091
- UMLS CUI [3,2]
- C2350229
Description
Anti-B1 dose (cold dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0768182
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C0009264
Description
Lot number of Anti-B1
Data type
text
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C1115660
Description
Anti-B1 dose (hot dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C0768182
- UMLS CUI [2,1]
- C3174092
- UMLS CUI [2,2]
- C2350229
Description
Lot number of Anti-B1
Data type
text
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C1115660
Description
Iodine-131 Anti-B1 (prescripted)
Data type
float
Measurement units
- mCi
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0278329
Description
Lot number (Nordion)
Data type
text
Alias
- UMLS CUI [1]
- C1115660
Description
Whole body dose (prescribed)
Data type
float
Measurement units
- cGy
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0444584
Description
Was dose attenuated for obesity?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1707811
- UMLS CUI [1,3]
- C0028754
Description
Did infusion rate need to be adjusted?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C2826232
Description
Specify adjustment of infusion
Data type
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C2348235
Description
Specify other adjustment of infusion
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Check all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C2348235
Description
Specify other reason for adjustment
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Description
If yes, please record on AE page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Was patient compliant with SSKI, Lugol's solution, or potassium iodide tablets as described in protocol?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1564085
- UMLS CUI [2,1]
- C1321605
- UMLS CUI [2,2]
- C0032831
- UMLS CUI [3,1]
- C1321605
- UMLS CUI [3,2]
- C0065234
Description
If patient was not compliant, please explain
Data type
text
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0681841
Description
Infusion Record - Vital Signs (Therapeutic Dose)
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C0518766
- UMLS CUI-3
- C0178602
- UMLS CUI-4
- C0302350
Description
24 hr
Data type
time
Alias
- UMLS CUI [1]
- C0040223
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
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
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Infusion Record
- StudyEvent: ODM
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C3174092 (UMLS CUI [2,1])
C2350229 (UMLS CUI [2,2])
C1115660 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
C2826232 (UMLS CUI [1,2])
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C0456081 (UMLS CUI [1,2])
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C2348235 (UMLS CUI [1,4])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0518766 (UMLS CUI-2)
C2094191 (UMLS CUI-3)
C0178602 (UMLS CUI-2)
C0302350 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0009264 (UMLS CUI [3])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C2350229 (UMLS CUI [3])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0009264 (UMLS CUI [3])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C0009264 (UMLS CUI [3,2])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C2350229 (UMLS CUI [3])
C0178602 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C1696091 (UMLS CUI [3,1])
C2350229 (UMLS CUI [3,2])
C3174092 (UMLS CUI [2,1])
C0009264 (UMLS CUI [2,2])
C1115660 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C2350229 (UMLS CUI [2,2])
C1115660 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
C1707811 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
C2826232 (UMLS CUI [1,2])
C0456081 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0456081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C1564085 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0032831 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0065234 (UMLS CUI [3,2])
C0681841 (UMLS CUI [1,2])
C0518766 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0302350 (UMLS CUI-4)