ID

31177

Beschrijving

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin This form is to be completed every 6 months once the patient has entered long-term follow-up.

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  1. 25-07-18 25-07-18 -
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see clinicaltrials.gov

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25 juli 2018

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Creative Commons BY 4.0
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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Engels

Long-Term Follow-Up for Survival & Disease Status

1 Formulieren  
Default Itemgroup
Beschrijving

Default Itemgroup

Site number
Beschrijving

Site number

Datatype

text

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient number
Beschrijving

Patient number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Patient initials
Beschrijving

Patient initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Patient status
Beschrijving

Patient status

Datatype

text

Alias
UMLS CUI [1]
C0449437
Date last known alive
Beschrijving

Date last known alive

Datatype

date

Alias
UMLS CUI [1,1]
C3274947
UMLS CUI [1,2]
C0011008
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
How contact was made
Beschrijving

Contact

Datatype

text

Alias
UMLS CUI [1]
C2051442
Does the patient have an ongoing response to Iodine I 131 Tositumomab?
Beschrijving

Iodine I 131 Tositumomab

Datatype

boolean

Alias
UMLS CUI [1]
C0768182
Additional therapy for NHL since the last LTFU
Beschrijving

Additional therapy for NHL since the last LTFU

Alias
UMLS CUI-1
C0024305
UMLS CUI-2
C1706712
Has any additional therapy for NHL been administered? (If yes, specify therapy and start dates in comment section below)
Beschrijving

additional therapy for NHL

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1706712
Myelodysplasia
Beschrijving

Myelodysplasia

Alias
UMLS CUI-1
C0026985
Has the patient had a documented (bone marrow biopsy) new diagnosis of myelodysplasia?
Beschrijving

Myelodysplasia diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C0011900
If yes, date of diagnosis
Beschrijving

Myelodysplasia Date of diagnosis

Datatype

date

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C2316983
Another malignancy
Beschrijving

Another malignancy

Alias
UMLS CUI-1
C0006826
Has the patient had a new diagnosis of a secondary malignancy? (If yes, please specify type of malignancy)
Beschrijving

Malignancy Diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
if yes, date of diagnosis
Beschrijving

Malignancy, Date of Diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2316983
Thyroid medication
Beschrijving

Thyroid medication

Alias
UMLS CUI-1
C0040128
UMLS CUI-2
C0013227
Is the patient taking thyroid medication?
Beschrijving

Thyroid medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
If yes, drug name
Beschrijving

Thyroid medication; drug name

Datatype

text

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2360065
Start Date
Beschrijving

Thyroid medication; Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
Comments
Beschrijving

Comments

Alias
UMLS CUI-1
C0947611
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Long-Term Follow-Up for Survival & Disease Status

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site number
Item
Site number
text
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient number
text
C1830427 (UMLS CUI [1])
Patient initials
Item
Patient initials
text
C2986440 (UMLS CUI [1])
Item
Patient status
text
C0449437 (UMLS CUI [1])
Patient status
Code List
Patient status
CL Item
Alive (1)
CL Item
Dead (complete "Notification of Patient Death" Form) (2)
CL Item
Lost to follow-up (3)
Date last known alive
Item
Date last known alive
date
C3274947 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
How contact was made
text
C2051442 (UMLS CUI [1])
contact
Code List
How contact was made
CL Item
Tumor registry (1)
CL Item
Contact with patient (2)
CL Item
Contact with MD (3)
CL Item
Other (4)
CL Item
Other (4)
Iodine I 131 Tositumomab
Item
Does the patient have an ongoing response to Iodine I 131 Tositumomab?
boolean
C0768182 (UMLS CUI [1])
Item Group
Additional therapy for NHL since the last LTFU
C0024305 (UMLS CUI-1)
C1706712 (UMLS CUI-2)
additional therapy for NHL
Item
Has any additional therapy for NHL been administered? (If yes, specify therapy and start dates in comment section below)
boolean
C0024305 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
Item Group
Myelodysplasia
C0026985 (UMLS CUI-1)
Myelodysplasia diagnosis
Item
Has the patient had a documented (bone marrow biopsy) new diagnosis of myelodysplasia?
boolean
C0026985 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Myelodysplasia Date of diagnosis
Item
If yes, date of diagnosis
date
C0026985 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item Group
Another malignancy
C0006826 (UMLS CUI-1)
Malignancy Diagnosis
Item
Has the patient had a new diagnosis of a secondary malignancy? (If yes, please specify type of malignancy)
boolean
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Malignancy, Date of Diagnosis
Item
if yes, date of diagnosis
boolean
C0006826 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item Group
Thyroid medication
C0040128 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Thyroid medication
Item
Is the patient taking thyroid medication?
boolean
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Thyroid medication; drug name
Item
If yes, drug name
text
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Thyroid medication; Start Date
Item
Start Date
date
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item Group
Comments
C0947611 (UMLS CUI-1)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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