ID

31379

Beschreibung

Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Stichworte

Versionen (2)
  1. 31.07.18 31.07.18 -
  2. 18.08.18 18.08.18 -
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GlaxoSmithKline

Hochgeladen am

18. August 2018

DOI

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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593

Englisch

Long Term Follow- Up for Survival and Disease Status

1 Formulare  
Patient Status
Beschreibung

Patient Status

Alias
UMLS CUI-1
C0449437
Patient Status
Beschreibung

Patient Status

Datentyp

text

Alias
UMLS CUI [1]
C0449437
Date of status
Beschreibung

Date of status

Datentyp

date

Alias
UMLS CUI [1,1]
C0449437
UMLS CUI [1,2]
C0011008
How was contact made?
Beschreibung

How was contact made

Datentyp

text

Alias
UMLS CUI [1]
C1705415
If other type of contact, please specify
Beschreibung

Communication Contact; Other; Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1705415
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Does the patient have an ongoing response to Iodine-131 Tositumomab?
Beschreibung

iodine-131-tositumomab; Response to treatment; Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0521982
UMLS CUI [1,3]
C0549178
Since the time the last LTFU was completed...
Beschreibung

Since the time the last LTFU was completed...

Alias
UMLS CUI-1
C1517942
UMLS CUI-2
C3872643
Has any additional therapy for NHL been administered?
Beschreibung

If yes, specify below and provide applicable data.

Datentyp

boolean

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

Subsequent NHL Therapy since last LTFU

Alias
UMLS CUI-1
C0024305
UMLS CUI-2
C0087111
UMLS CUI-3
C1514923
Subsequent NHL Therapy since last LTFU
Beschreibung

Subsequent NHL Therapy since last LTFU

Datentyp

text

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1514923
Start Date Subsequent NHL Therapy
Beschreibung

Start Date Subsequent NHL Therapy

Datentyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1514923
UMLS CUI [1,4]
C0808070
Subsequent NHL Therapy Stop Date
Beschreibung

Subsequent NHL Therapy Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1514923
UMLS CUI [1,4]
C0806020
Total number of cycles
Beschreibung

Total number of cycles

Datentyp

integer

Alias
UMLS CUI [1]
C2045831
Diagnosis of malignancy
Beschreibung

Diagnosis of malignancy

Alias
UMLS CUI-1
C0006826
UMLS CUI-2
C0011900
Has the patient had a documented diagnosis of myelodysplasia?
Beschreibung

myelodysplasia

Datentyp

boolean

Alias
UMLS CUI [1]
C0026985
If diagnosis of myelodysplasia, date of diagnosis
Beschreibung

Myelodysplasia; Date of diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C2316983
Has the patient had a documented diagnosis of AML?
Beschreibung

Leukemia, Myelocytic, Acute

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
If diagnosis of AML, date of diagnosis
Beschreibung

Leukemia, Myelocytic, Acute; Date of diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C2316983
Has the patient had a diagnosis of another malignancy?
Beschreibung

Malignant Neoplasms; Diagnosis; Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205394
If diagnosis of other malignancy, date of diagnosis
Beschreibung

Malignant Neoplasms; Diagnosis; Other; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0011008
If diagnosis of other malignancy, type of malignancy
Beschreibung

Malignant Neoplasms; Diagnosis; Other; Type - attribute

Datentyp

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0332307
Laboratory
Beschreibung

Laboratory

Alias
UMLS CUI-1
C0022885
TSH Date
Beschreibung

Thyroid stimulating hormone measurement; Date in time

Datentyp

date

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

TSH Result

Datentyp

float

Maßeinheiten
  • u[iU]/mL
Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1274040
u[iU]/mL
TSH not done
Beschreibung

TSH not done

Datentyp

text

Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1272696
Has the patient begun thyroid replacement therapy since last LTFU?
Beschreibung

Thyroid hormone replacement therapy; Long-term Follow-up; Since last encounter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2242640
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C3872643
Thyroid replacement therapy start date
Beschreibung

Thyroid replacement therapy start date

Datentyp

date

Alias
UMLS CUI [1,1]
C2242640
UMLS CUI [1,2]
C0808070
Thyroid replacement therapy Drug name
Beschreibung

Thyroid replacement therapy Drug name

Datentyp

text

Alias
UMLS CUI [1,1]
C2242640
UMLS CUI [1,2]
C2360065
Was a HAMA obtained since the last LTFU?
Beschreibung

Human anti-mouse antibody; Long-term Follow-up; Since last encounter

Datentyp

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C3872643
If HAMA was obtained, enter accession number
Beschreibung

Human anti-mouse antibody; Accession Number (identifier)

Datentyp

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1510755
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of evaluation
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
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Ähnliche Modelle

Long Term Follow- Up for Survival and Disease Status

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Status
C0449437 (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 of status
Item
Date of status
date
C0449437 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
How was contact made?
text
C1705415 (UMLS CUI [1])
How was contact made
Code List
How was contact made?
CL Item
Tumor registry (1)
CL Item
Contact with patient (2)
CL Item
Contact with MD (3)
CL Item
Contact with family (4)
CL Item
Other (5)
Communication Contact; Other; Specification
Item
If other type of contact, please specify
text
C1705415 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
iodine-131-tositumomab; Response to treatment; Continuous
Item
Does the patient have an ongoing response to Iodine-131 Tositumomab?
boolean
C0768182 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item Group
Since the time the last LTFU was completed...
C1517942 (UMLS CUI-1)
C3872643 (UMLS CUI-2)
Additional Therapy; Lymphoma, Non-Hodgkin
Item
Has any additional therapy for NHL been administered?
boolean
C1706712 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
Item Group
Subsequent NHL Therapy since last LTFU
C0024305 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1514923 (UMLS CUI-3)
Subsequent NHL Therapy since last LTFU
Item
Subsequent NHL Therapy since last LTFU
text
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1514923 (UMLS CUI [1,3])
Start Date Subsequent NHL Therapy
Item
Start Date Subsequent NHL Therapy
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1514923 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Subsequent NHL Therapy Stop Date
Item
Subsequent NHL Therapy Stop Date
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1514923 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Total number of cycles
Item
Total number of cycles
integer
C2045831 (UMLS CUI [1])
Item Group
Diagnosis of malignancy
C0006826 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
myelodysplasia
Item
Has the patient had a documented diagnosis of myelodysplasia?
boolean
C0026985 (UMLS CUI [1])
Myelodysplasia; Date of diagnosis
Item
If diagnosis of myelodysplasia, date of diagnosis
date
C0026985 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Leukemia, Myelocytic, Acute
Item
Has the patient had a documented diagnosis of AML?
boolean
C0023467 (UMLS CUI [1])
Leukemia, Myelocytic, Acute; Date of diagnosis
Item
If diagnosis of AML, date of diagnosis
text
C0023467 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Malignant Neoplasms; Diagnosis; Other
Item
Has the patient had a diagnosis of another malignancy?
boolean
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Malignant Neoplasms; Diagnosis; Other; Date in time
Item
If diagnosis of other malignancy, date of diagnosis
date
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Malignant Neoplasms; Diagnosis; Other; Type - attribute
Item
If diagnosis of other malignancy, type of malignancy
text
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Item Group
Laboratory
C0022885 (UMLS CUI-1)
Thyroid stimulating hormone measurement; Date in time
Item
TSH Date
date
C0202230 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TSH Result
Item
TSH Result
float
C0202230 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
TSH not done
text
C0202230 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
TSH not done
Code List
TSH not done
CL Item
not done (1)
Thyroid hormone replacement therapy; Long-term Follow-up; Since last encounter
Item
Has the patient begun thyroid replacement therapy since last LTFU?
boolean
C2242640 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
Thyroid replacement therapy start date
Item
Thyroid replacement therapy start date
date
C2242640 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Thyroid replacement therapy Drug name
Item
Thyroid replacement therapy Drug name
text
C2242640 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Item
Was a HAMA obtained since the last LTFU?
text
C1291910 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
undefined item
Code List
Was a HAMA obtained since the last LTFU?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Human anti-mouse antibody; Accession Number (identifier)
Item
If HAMA was obtained, enter accession number
text
C1291910 (UMLS CUI [1,1])
C1510755 (UMLS CUI [1,2])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Assessment Date
Item
Date of evaluation
date
C2985720 (UMLS CUI [1])
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