ID

30261

Description

https://clinicaltrials.gov/show/NCT00989664 Clarification Form, Doses and Additional Hematology Laboratory Results 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

Clarification Form, Doses and Additional Hematology Laboratory Results

1 forms  
Clarification Form
Description

Clarification Form

Alias
UMLS CUI-1
C2986669
UMLS CUI-2
C1546922
Form Number
Description

Please detail below any previous or additional information that requires further description.

Data type

integer

Alias
UMLS CUI [1,1]
C1706499
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C0237753
Series Page Number
Description

Series Page Number

Data type

integer

Alias
UMLS CUI [1,1]
C1706499
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C0237753
Comments: clearly identify the item to which the comment applies (e.g., date, time, etc.)
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Administered Doses
Description

Administered Doses

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1521801
Dose Specification
Description

Dose Specification

Data type

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C2348235
Date administered
Description

Date administered

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Actual lodine-131 Anti-B1 Antibody dose administered
Description

Actual Dose administered

Data type

integer

Measurement units
  • mCi
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1521801
mCi
Additional Hematology
Description

Additional Hematology

Alias
UMLS CUI-1
C0474523
UMLS CUI-2
C0022885
Visit:
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Date on or after:
Description

Date on or after

Data type

date

Alias
UMLS CUI [1]
C1320303
Date on or before:
Description

Date on or before

Data type

date

Alias
UMLS CUI [1]
C1320303
Laboratory Results - Date:
Description

Laboratory Results

Data type

date

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0011008
ANC:
Description

ANC

Data type

integer

Measurement units
  • 10³/mm³
Alias
UMLS CUI [1]
C0948762
10³/mm³
Hgb:
Description

Hgb

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Plt:
Description

Plt

Data type

integer

Measurement units
  • 10³/mm³
Alias
UMLS CUI [1]
C0005821
10³/mm³
WBC:
Description

WBC

Data type

integer

Measurement units
  • 10³/mm³
Alias
UMLS CUI [1]
C0023508
10³/mm³
Unable to Obtain - Specify:
Description

Unable to Obtain

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1299582
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Clarification Form, Doses and Additional Hematology Laboratory Results

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Clarification Form
C2986669 (UMLS CUI-1)
C1546922 (UMLS CUI-2)
Form Number
Item
Form Number
integer
C1706499 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Series Page Number
Item
Series Page Number
integer
C1706499 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Comments
Item
Comments: clearly identify the item to which the comment applies (e.g., date, time, etc.)
text
C0947611 (UMLS CUI [1])
Item Group
Administered Doses
C0678766 (UMLS CUI-1)
C1521801 (UMLS CUI-2)
Item
Dose Specification
integer
C3174092 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Dose Specification
Code List
Dose Specification
CL Item
Dosimetric Dose (1)
CL Item
Therapeutic Dose (2)
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual Dose administered
Item
Actual lodine-131 Anti-B1 Antibody dose administered
integer
C3174092 (UMLS CUI [1,1])
C1521801 (UMLS CUI [1,2])
Item Group
Additional Hematology
C0474523 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Visit
Item
Visit:
text
C0545082 (UMLS CUI [1])
Date on or after
Item
Date on or after:
date
C1320303 (UMLS CUI [1])
Date on or before
Item
Date on or before:
date
C1320303 (UMLS CUI [1])
Laboratory Results
Item
Laboratory Results - Date:
date
C1254595 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
ANC
Item
ANC:
integer
C0948762 (UMLS CUI [1])
Hgb
Item
Hgb:
float
C0019046 (UMLS CUI [1])
Plt
Item
Plt:
integer
C0005821 (UMLS CUI [1])
WBC
Item
WBC:
integer
C0023508 (UMLS CUI [1])
Unable to Obtain
Item
Unable to Obtain - Specify:
text
C0022885 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Item Group
Administration
C1320722 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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