ID

30832

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. 25.06.18 25.06.18 -
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see clinicaltrials.gov

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25. Juni 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 vital status

Datentyp

text

Alias
UMLS CUI [1]
C1148433
Date of status
Beschreibung

Date of status

Datentyp

date

Alias
UMLS CUI [1]
C2985720
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?
Beschreibung

additional therapy for NHL

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1706712
Subsequent NHL therapy since last LTFU
Beschreibung

Lymphoma, Non-Hodgkin Therapeutic procedure Following Visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0545082
Start Date
Beschreibung

Start Date, Lymphoma, Non-Hodgkin, Therapeutic procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

End date, Lymphoma, Non-Hodgkin, Therapeutic procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0806020
Total number of cycles
Beschreibung

chemotherapeutics regimen total number of cycles ordered, Lymphoma, Non-Hodgkin, Therapeutic procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C2045831
UMLS CUI [1,2]
C0024305
Myelodysplasia
Beschreibung

Myelodysplasia

Alias
UMLS CUI-1
C0026985
Has the patient had a documented 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
AML
Beschreibung

AML

Alias
UMLS CUI-1
C0023467
Has the patient had a documented diagnosis of AML?
Beschreibung

AML diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0011900
If yes, date of diagnosis
Beschreibung

AML date of diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C2316983
Another malignancy
Beschreibung

Another malignancy

Alias
UMLS CUI-1
C0006826
Has the patient had a diagnosis of another 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

date

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2316983
TSH measurement
Beschreibung

TSH measurement

Alias
UMLS CUI-1
C0202230
Date
Beschreibung

TSH measurement Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C0011008
Result
Beschreibung

TSH measurement Result

Datentyp

float

Maßeinheiten
  • µIU/mL
Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1254595
µIU/mL
Not done
Beschreibung

TSH measurement Not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1272696
HAMA
Beschreibung

HAMA

Alias
UMLS CUI-1
C1291910
Was a HAMA obtained since the last LTFU?
Beschreibung

HAMA since last encounter

Datentyp

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C3872643
If yes, enter accession #
Beschreibung

HAMA accession number

Datentyp

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1510755
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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
C1148433 (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 of status
Item
Date of status
date
C2985720 (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?
boolean
C0024305 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
Lymphoma, Non-Hodgkin Therapeutic procedure Following Visit
Item
Subsequent NHL therapy since last LTFU
text
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Start Date, Lymphoma, Non-Hodgkin, Therapeutic procedure
Item
Start Date
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
End date, Lymphoma, Non-Hodgkin, Therapeutic procedure
Item
Stop Date
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
chemotherapeutics regimen total number of cycles ordered, Lymphoma, Non-Hodgkin, Therapeutic procedure
Item
Total number of cycles
text
C2045831 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
Item Group
Myelodysplasia
C0026985 (UMLS CUI-1)
Myelodysplasia diagnosis
Item
Has the patient had a documented 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
AML
C0023467 (UMLS CUI-1)
AML diagnosis
Item
Has the patient had a documented diagnosis of AML?
boolean
C0023467 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
AML date of diagnosis
Item
If yes, date of diagnosis
date
C0023467 (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 diagnosis of another malignancy?
boolean
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Malignancy Date of diagnosis
Item
If yes, date of diagnosis
date
C0006826 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item Group
TSH measurement
C0202230 (UMLS CUI-1)
TSH measurement Date
Item
Date
date
C0202230 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TSH measurement Result
Item
Result
float
C0202230 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
TSH measurement Not done
Item
Not done
boolean
C0202230 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
HAMA
C1291910 (UMLS CUI-1)
Item
Was a HAMA obtained since the last LTFU?
text
C1291910 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
HAMA since last encounter
Code List
Was a HAMA obtained since the last LTFU?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
HAMA accession number
Item
If yes, enter accession #
text
C1291910 (UMLS CUI [1,1])
C1510755 (UMLS CUI [1,2])
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