ID

30261

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00989664

Nyckelord

Versioner (1)
  1. 25.05.18 25.05.18 -
Rättsinnehavare

GlaxoSmithKline (GSK)

Uppladdad den

25. Mai 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

Engelsk

Clarification Form, Doses and Additional Hematology Laboratory Results

1 Formulär  
Clarification Form
Beskrivning

Clarification Form

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

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

Datatyp

integer

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

Series Page Number

Datatyp

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.)
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Administered Doses
Beskrivning

Administered Doses

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

Dose Specification

Datatyp

integer

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

Date administered

Datatyp

date

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

Actual Dose administered

Datatyp

integer

Måttenheter
  • mCi
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1521801
mCi
Additional Hematology
Beskrivning

Additional Hematology

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

Visit

Datatyp

text

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

Date on or after

Datatyp

date

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

Date on or before

Datatyp

date

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

Laboratory Results

Datatyp

date

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

ANC

Datatyp

integer

Måttenheter
  • 10³/mm³
Alias
UMLS CUI [1]
C0948762
10³/mm³
Hgb:
Beskrivning

Hgb

Datatyp

float

Måttenheter
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Plt:
Beskrivning

Plt

Datatyp

integer

Måttenheter
  • 10³/mm³
Alias
UMLS CUI [1]
C0005821
10³/mm³
WBC:
Beskrivning

WBC

Datatyp

integer

Måttenheter
  • 10³/mm³
Alias
UMLS CUI [1]
C0023508
10³/mm³
Unable to Obtain - Specify:
Beskrivning

Unable to Obtain

Datatyp

text

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

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Clarification Form, Doses and Additional Hematology Laboratory Results

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial