ID
31362
Description
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin
Keywords
Versions (3)
- 7/9/18 7/9/18 -
- 7/21/18 7/21/18 -
- 8/18/18 8/18/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 18, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593
Infusion Record Dosimetric Dose - Day 0 (Visit 2)
- StudyEvent: ODM
Description
HAMA
Alias
- UMLS CUI-1
- C1291910
Description
Infusion Time started (24 hour clock)
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C1301880
Description
(cold)
Data type
time
Alias
- UMLS CUI [1,1]
- C1142540
- UMLS CUI [1,2]
- C1301880
Description
(cold flush)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0016382
- UMLS CUI [1,3]
- C0009264
- UMLS CUI [1,4]
- C1301880
Description
(hot)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2350229
- UMLS CUI [1,3]
- C1301880
Description
(hot flush)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0600142
- UMLS CUI [1,3]
- C1301880
Description
Infusion Time finished (24 hour clock)
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C1522314
Description
(cold)
Data type
time
Alias
- UMLS CUI [1,1]
- C1142540
- UMLS CUI [1,2]
- C1522314
Description
(cold flush)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0016382
- UMLS CUI [1,3]
- C0009264
- UMLS CUI [1,4]
- C1522314
Description
(hot)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2350229
- UMLS CUI [1,3]
- C1522314
Description
(hot flush)
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0600142
- UMLS CUI [1,3]
- C1522314
Description
Doses
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C0750480
Description
Anti- B1 dose (cold dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0009264
Description
Lot number of Anti- B1
Data type
text
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C1115660
- UMLS CUI [1,3]
- C0009264
Description
Anti- B1 (hot dose)
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C2350229
Description
Lot number of Anti- B1
Data type
text
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0768182
- UMLS CUI [1,3]
- C2350229
Description
Iodine- 131 Anti- B1 (prescribed)
Data type
float
Measurement units
- mCi
Alias
- UMLS CUI [1,1]
- C0768182
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [1,3]
- C0278329
Description
Lot number (Nordion)
Data type
text
Alias
- UMLS CUI [1]
- C1115660
Description
Infusion rate
Alias
- UMLS CUI-1
- C2964135
Description
Infusion Rate; Adjustment Action
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
Description
Adjustment; Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C2348235
Description
Other; Specification
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
Infusion Rate; Adjustment Action; Indication of (contextual qualifier)
Data type
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C0456081
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C2348235
Description
Indication; Other; Specification
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
Record Vital Signs [every 15 minutes during both (cold and hot) infusions]
Alias
- UMLS CUI-1
- C0518766
Description
Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0040223
Description
BP
Data type
text
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
float
Measurement units
- C°
Alias
- UMLS CUI [1]
- C0039476
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Adverse Experience
Alias
- UMLS CUI-1
- C0877248
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- StudyEvent: ODM
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C2350229 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0600142 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C1115660 (UMLS CUI [1,2])
C0009264 (UMLS CUI [1,3])
C3174092 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C0768182 (UMLS CUI [1,2])
C2350229 (UMLS CUI [1,3])
C0678766 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
C0456081 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
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])
C0040223 (UMLS CUI [1,2])