ID

30262

Description

https://clinicaltrials.gov/show/NCT00989664 Worksheet #3 - Gamma Camera Whole Body Dosimetry Daily Data Sheet 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)
  1. 5/25/18 5/25/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

May 25, 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

English

Worksheet #3 - Gamma Camera Whole Body Dosimetry Daily Data Sheet

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Patient Identification Number:
Description

Patient Identification Number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient Initials:
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Dosimetric Dose:
Description

Dosimetric Dose

Data type

integer

Alias
UMLS CUI [1]
C3174092
Prepared Activity:
Description

Prepared Activity

Data type

integer

Measurement units
  • mCi
Alias
UMLS CUI [1]
C0013227
mCi
Date & Time of Infusion Start:
Description

Date & Time of Infusion Start

Data type

datetime

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1301880
Residual Activity (Infusion system):
Description

Residual Activity (Infusion system)

Data type

integer

Measurement units
  • mCi
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1609982
mCi
Net Administered Activity:
Description

Net Administered Activity

Data type

integer

Measurement units
  • mCi
Alias
UMLS CUI [1]
C0013227
mCi
End of Infusion (including Flushing):
Description

End of Infusion

Data type

datetime

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C1522314
Camera Name:
Description

Camera name

Data type

text

Alias
UMLS CUI [1,1]
C0179533
UMLS CUI [1,2]
C0027365
Patient height:
Description

Patient height

Data type

integer

Measurement units
  • ft/cm
Alias
UMLS CUI [1]
C0005890
ft/cm
Patient weight
Description

Patient weight

Data type

float

Measurement units
  • lb/kg
Alias
UMLS CUI [1]
C0005910
lb/kg
Patient gender:
Description

Patient gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Patient wt limit:
Description

Patient wt limit

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Is Patient above Limit?
Description

Patient above limit

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Post Administration of Dosimetric Dose
Description

Post Administration of Dosimetric Dose

Alias
UMLS CUI-1
C0043299
UMLS CUI-2
C0439568
Date
Description

Day of Examination

Data type

integer

Alias
UMLS CUI [1]
C2826643
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Gamma Camera Height From Table (cm)
Description

Gamma Camera Height From Table

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0810610
UMLS CUI [1,2]
C0443288
cm
Whole Body Scan Field of View (cm)
Description

Whole Body Scan Field of View

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0412583
cm
Whole Body Gamma Camera Counts
Description

Whole Body Gamma Camera Counts

Data type

integer

Alias
UMLS CUI [1,1]
C0810610
UMLS CUI [1,2]
C0444584
Background Counts
Description

Background Counts

Data type

integer

Alias
UMLS CUI [1]
C0810610
Time started
Description

Time started

Data type

time

Alias
UMLS CUI [1]
C1301880
Total Counts: Anterior (Cpa)
Description

Total Counts: Anterior

Data type

integer

Alias
UMLS CUI [1,1]
C0205094
UMLS CUI [1,2]
C0810610
Total Counts: Posterior (Cpa)
Description

Total Counts: Posterior

Data type

integer

Alias
UMLS CUI [1,1]
C0810610
UMLS CUI [1,2]
C0205095
Patient total body counts
Description

Patient total body counts

Data type

integer

Alias
UMLS CUI [1,1]
C0444584
UMLS CUI [1,2]
C0810610
Time started
Description

Time started

Data type

time

Alias
UMLS CUI [1]
C1301880
Total Counts: Anterior (Cpa)
Description

Total Counts: Anterior

Data type

integer

Alias
UMLS CUI [1,1]
C0205094
UMLS CUI [1,2]
C0810610
Total Counts: Posterior (Cpa)
Description

Total Counts: Posterior

Data type

integer

Alias
UMLS CUI [1,1]
C0810610
UMLS CUI [1,2]
C0205095
Time from Start of I-131 Anti-B1 Infusion to Start of Patient Image Acquisition
Description

Start of I-131 Anti-B1 Infusion

Data type

time

Measurement units
  • hr
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0810610
hr
Time from Start of I-131 Anti-B1 Infusion to Start of Patient Image Acquisition
Description

Start of I-131 Anti-B1 Infusion

Data type

time

Measurement units
  • hr
Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0574032
UMLS CUI [1,3]
C0810610
hr
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Similar models

Worksheet #3 - Gamma Camera Whole Body Dosimetry Daily Data Sheet

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Identification Number
Item
Patient Identification Number:
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials:
text
C2986440 (UMLS CUI [1])
Dosimetric Dose
Item
Dosimetric Dose:
integer
C3174092 (UMLS CUI [1])
Prepared Activity
Item
Prepared Activity:
integer
C0013227 (UMLS CUI [1])
Date & Time of Infusion Start
Item
Date & Time of Infusion Start:
datetime
C0574032 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Residual Activity (Infusion system)
Item
Residual Activity (Infusion system):
integer
C0574032 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
Net Administered Activity
Item
Net Administered Activity:
integer
C0013227 (UMLS CUI [1])
End of Infusion
Item
End of Infusion (including Flushing):
datetime
C0574032 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Camera name
Item
Camera Name:
text
C0179533 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Patient height
Item
Patient height:
integer
C0005890 (UMLS CUI [1])
Patient weight
Item
Patient weight
float
C0005910 (UMLS CUI [1])
Item
Patient gender:
integer
C0079399 (UMLS CUI [1])
Patient gender
Code List
Patient gender:
CL Item
M (1)
CL Item
F (2)
Patient wt limit
Item
Patient wt limit:
float
C0005910 (UMLS CUI [1])
Patient above limit
Item
Is Patient above Limit?
boolean
C0005910 (UMLS CUI [1])
Item Group
Post Administration of Dosimetric Dose
C0043299 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Date
integer
C2826643 (UMLS CUI [1])
Day of Examination
Code List
Date
CL Item
Day 0 (1)
CL Item
Day 2 (2)
CL Item
Day 3 (3)
CL Item
Day 4 (4)
CL Item
Day 6 (5)
CL Item
Day 7 (6)
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Gamma Camera Height From Table
Item
Gamma Camera Height From Table (cm)
integer
C0810610 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Whole Body Scan Field of View
Item
Whole Body Scan Field of View (cm)
integer
C0412583 (UMLS CUI [1])
Whole Body Gamma Camera Counts
Item
Whole Body Gamma Camera Counts
integer
C0810610 (UMLS CUI [1,1])
C0444584 (UMLS CUI [1,2])
Background Counts
Item
Background Counts
integer
C0810610 (UMLS CUI [1])
Time started
Item
Time started
time
C1301880 (UMLS CUI [1])
Total Counts: Anterior
Item
Total Counts: Anterior (Cpa)
integer
C0205094 (UMLS CUI [1,1])
C0810610 (UMLS CUI [1,2])
Total Counts: Posterior
Item
Total Counts: Posterior (Cpa)
integer
C0810610 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
Patient total body counts
Item
Patient total body counts
integer
C0444584 (UMLS CUI [1,1])
C0810610 (UMLS CUI [1,2])
Time started
Item
Time started
time
C1301880 (UMLS CUI [1])
Total Counts: Anterior
Item
Total Counts: Anterior (Cpa)
integer
C0205094 (UMLS CUI [1,1])
C0810610 (UMLS CUI [1,2])
Total Counts: Posterior
Item
Total Counts: Posterior (Cpa)
integer
C0810610 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
Start of I-131 Anti-B1 Infusion
Item
Time from Start of I-131 Anti-B1 Infusion to Start of Patient Image Acquisition
time
C0768182 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0810610 (UMLS CUI [1,3])
Start of I-131 Anti-B1 Infusion
Item
Time from Start of I-131 Anti-B1 Infusion to Start of Patient Image Acquisition
time
C0768182 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0810610 (UMLS CUI [1,3])
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