ID

31177

Beschreibung

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

Hochgeladen am

25. Juli 2018

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Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755

Englisch

Long-Term Follow-Up for Survival & Disease Status

1 Formulare  
Default Itemgroup
Beschreibung

Default Itemgroup

Site number
Beschreibung

Site number

Datentyp

text

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

Patient number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Patient initials
Beschreibung

Patient initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient status
Beschreibung

Patient status

Datentyp

text

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

Date last known alive

Datentyp

date

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

Date of last contact

Datentyp

date

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

Contact

Datentyp

text

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

Iodine I 131 Tositumomab

Datentyp

boolean

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

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)
Beschreibung

additional therapy for NHL

Datentyp

boolean

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

Myelodysplasia

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

Myelodysplasia diagnosis

Datentyp

boolean

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

Myelodysplasia Date of diagnosis

Datentyp

date

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

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)
Beschreibung

Malignancy Diagnosis

Datentyp

boolean

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

Malignancy, Date of Diagnosis

Datentyp

boolean

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

Thyroid medication

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

Thyroid medication

Datentyp

boolean

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

Thyroid medication; drug name

Datentyp

text

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

Thyroid medication; Start Date

Datentyp

date

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

Comments

Alias
UMLS CUI-1
C0947611
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Long-Term Follow-Up for Survival & Disease Status

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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