ID
30233
Description
https://clinicaltrials.gov/show/NCT00989664 Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7 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
Keywords
Versions (1)
- 5/23/18 5/23/18 -
Copyright Holder
GlaxoSmithKline (GSK)
Uploaded on
May 23, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664
Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Time (24 hr)
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
BP (mmHg)
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse (bpm)
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temp.
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
If yes, please record on AE page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Therapy Dose - Day 7
Alias
- UMLS CUI-1
- C3174092
- UMLS CUI-2
- C0304229
Description
Date administered
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
Description
Day 5 HAMA date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1291910
Description
HAMA Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C1291910
- UMLS CUI [1,2]
- C1274040
Description
Time started (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Description
Time started (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Description
Time started (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Description
Time started (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1301880
Description
Time finished (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Description
Time finished (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Description
Time finished (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Description
Time finished (24 hour clock)
Data type
time
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C1522314
Description
Anti-B1 dose (cold dose)
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Description
Lot number of Anti-B1
Data type
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Description
Anti-B1 dose (hot dose)
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
Description
Lot number of Anti-B1
Data type
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
Description
lodine-131 Anti-B1 (prescribed)
Data type
integer
Measurement units
- mCi
Alias
- UMLS CUI [1]
- C0768182
Description
Lot number (Nordion)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C3854006
Description
Whole body dose (prescribed)
Data type
integer
Measurement units
- cGy
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0278329
- UMLS CUI [1,3]
- C0444584
Description
Dose attenuation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0028754
Description
Infusion rate adjustment
Data type
boolean
Alias
- UMLS CUI [1]
- C2964135
Description
Infusion rate adjustment
Data type
integer
Alias
- UMLS CUI [1]
- C2964135
Description
Reason for adjustment
Data type
integer
Alias
- UMLS CUI [1]
- C2826286
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Time (24 hr)
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
BP (mmHg)
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse (bpm)
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temp.
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
If yes, please record on AE page.
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Protocol compliance of patient
Data type
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Protocol compliance
Data type
text
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C1299582
Similar models
Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7
C0304229 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1291910 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (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])
C0011008 (UMLS CUI [1,2])
C1291910 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,2])
C1522314 (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])
C0278329 (UMLS CUI [1,2])
C0444584 (UMLS CUI [1,3])
C0028754 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])