ID

42075

Beschreibung

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Stichworte

Versionen (2)
  1. 18.03.21 18.03.21 -
  2. 18.03.21 18.03.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

18. März 2021

DOI

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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

Englisch

Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beschreibung

Site Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Demographics (Enrollment)
Beschreibung

Demographics (Enrollment)

Alias
UMLS CUI-1
C1704791
UMLS CUI-2
C1516879
Patient Body Weight
Beschreibung

Patient Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Patient Height
Beschreibung

Patient Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
For Coulter Use Only
Beschreibung

For Coulter Use Only

Alias
UMLS CUI-1
C3846158
Patient Enrollment Authorized by
Beschreibung

Patient Enrollment Authorized by

Datentyp

text

Alias
UMLS CUI [1,1]
C1555472
UMLS CUI [1,2]
C2700391
UMLS CUI [1,3]
C4041024
Enrollment Date
Beschreibung

Enrollment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0679646
UMLS CUI [1,3]
C1516879
Approved Dose
Beschreibung

Approved Dose

Datentyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205540
Other approved dose
Beschreibung

Other approved dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0205394
Adjust mCi dose for obesity
Beschreibung

Adjust mCi dose for obesity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0028754
Demographics (General Medical History)
Beschreibung

Demographics (General Medical History)

Alias
UMLS CUI-1
C1704791
UMLS CUI-2
C0262926
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnic Origin
Beschreibung

Ethnic Origin

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Other Ethnic Origin
Beschreibung

Other Ethnic Origin

Datentyp

text

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0205394
Medical History Date
Beschreibung

Medical History Date

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0011008
Medical History Date
Beschreibung

Medical History Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011008
General Medical History
Beschreibung

General Medical History

Alias
UMLS CUI-1
C0262926
Diagnosis/Condition
Beschreibung

Diagnosis/Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0012634
Date of Disease Onset
Beschreibung

Date of Disease Onset

Datentyp

partialDate

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0574845
Disease Status
Beschreibung

Disease Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Prior Therapy
Beschreibung

Prior Therapy

Alias
UMLS CUI-1
C1514463
Drugs
Beschreibung

Please report all prior therapies for NHL (i.e., chemotherapy, immunotherapy, steroidal therapy).

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Therapy Start Date
Beschreibung

Therapy Start Date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Therapy Stop Date
Beschreibung

Therapy Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C1531784
Number of Therapy Cycles
Beschreibung

Number of Therapy Cycles

Datentyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0750480
Therapeutic Outcome
Beschreibung

Therapeutic Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1547647
Duration of Response
Beschreibung

Duration of Response

Datentyp

integer

Maßeinheiten
  • months
Alias
UMLS CUI [1]
C0237585
months
Prior Radiation Therapy
Beschreibung

Prior Radiation Therapy

Alias
UMLS CUI-1
C0279134
Radiation Therapy Start Date
Beschreibung

Radiation Therapy Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0808070
Radiation Therapy Stop Date
Beschreibung

Radiation Therapy Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0806020
Radiation Therapy Total Dose
Beschreibung

Radiation Therapy Total Dose

Datentyp

integer

Maßeinheiten
  • cGy
Alias
UMLS CUI [1]
C2919490
cGy
Radiation Therapy Location
Beschreibung

Sites Treated

Datentyp

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0450429
History of Lymphoma
Beschreibung

History of Lymphoma

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0262926
Date of Diagnosis
Beschreibung

Date of Diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Stage at Diagnosis
Beschreibung

Stage at Diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C0011900
Stage at Enrollment
Beschreibung

Stage at Enrollment

Datentyp

integer

Alias
UMLS CUI [1,1]
C1300072
UMLS CUI [1,2]
C1516879
Lymphoma Cell Type
Beschreibung

Lymphoma Cell Type

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0449475
Cell Type
Beschreibung

Cell Type

Datentyp

integer

Alias
UMLS CUI [1]
C0449475
Timepoint
Beschreibung

Timepoint

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
Specify other Cell-Type
Beschreibung

Specify other Cell-Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0449475
UMLS CUI [1,2]
C2348235
Lymphoma Grade
Beschreibung

Lymphoma Grade

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0441800
Lymphoma Grade
Beschreibung

Lymphoma Grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0441800
Timepoint
Beschreibung

At diagnosis: only intermediate subtype of follicular large cell NHL

Datentyp

integer

Alias
UMLS CUI [1]
C2348792
History of Lymphoma - Extranodal Involvement
Beschreibung

History of Lymphoma - Extranodal Involvement

Datentyp

text

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C3899187
History of Lymphoma
Beschreibung

History of Lymphoma

Alias
UMLS CUI-1
C0024299
UMLS CUI-2
C0262926
History of Lymphoma - Extranodal Involvement at Enrollment
Beschreibung

History of Lymphoma - Extranodal Involvement at Enrollment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C3899187
CD20 Reactivity
Beschreibung

Please check one method

Datentyp

integer

Alias
UMLS CUI [1]
C0054946
Date tissue obtainted (CD20 Reactivity)
Beschreibung

Date tissue obtainted (CD20 Reactivity)

Datentyp

date

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0054946
Date of assay (CD20 Reactivity)
Beschreibung

Date of assay (CD20 Reactivity)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005507
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0054946
Does patient have evidence of bulky disease (> 500 gm)?
Beschreibung

Does patient have evidence of bulky disease (> 500 gm)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1511341
UMLS CUI [1,2]
C0332120
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Ähnliche Modelle

Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
integer
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Demographics (Enrollment)
C1704791 (UMLS CUI-1)
C1516879 (UMLS CUI-2)
Patient Body Weight
Item
Patient Body Weight
float
C0005910 (UMLS CUI [1])
Patient Height
Item
Patient Height
integer
C0005890 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
M (1)
CL Item
F (2)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
For Coulter Use Only
C3846158 (UMLS CUI-1)
Patient Enrollment Authorized by
Item
Patient Enrollment Authorized by
text
C1555472 (UMLS CUI [1,1])
C2700391 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
Enrollment Date
Item
Enrollment Date
date
C0011008 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Item
Approved Dose
integer
C0178602 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
Approved Dose
Code List
Approved Dose
CL Item
45 cGy (1)
CL Item
55 cGy (2)
CL Item
65 cGy (3)
CL Item
75 cGy (4)
CL Item
Other (5)
Other approved dose
Item
Other approved dose
text
C0178602 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Adjust mCi dose for obesity
Item
Adjust mCi dose for obesity
boolean
C1707811 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
Item Group
Demographics (General Medical History)
C1704791 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
M (1)
CL Item
F (2)
Item
Ethnic Origin
integer
C0015031 (UMLS CUI [1])
Ethnic Origin
Code List
Ethnic Origin
CL Item
White (1)
CL Item
Hispanic (2)
CL Item
Asian (3)
CL Item
Black (4)
CL Item
Native American (5)
CL Item
Othe (6)
Other Ethnic Origin
Item
Other Ethnic Origin
text
C0015031 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Medical History Date
C0262926 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Medical History Date
Item
Medical History Date
date
C0262926 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
General Medical History
C0262926 (UMLS CUI-1)
Diagnosis/Condition
Item
Diagnosis/Condition
text
C0011900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Date of Disease Onset
Item
Date of Disease Onset
partialDate
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Disease Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease Status
Code List
Disease Status
CL Item
Active (1)
CL Item
Inactive (2)
Item Group
Prior Therapy
C1514463 (UMLS CUI-1)
Drugs
Item
Drugs
text
C0013227 (UMLS CUI [1])
Therapy Start Date
Item
Therapy Start Date
date
C3173309 (UMLS CUI [1])
Therapy Stop Date
Item
Therapy Stop Date
date
C1531784 (UMLS CUI [1])
Number of Therapy Cycles
Item
Number of Therapy Cycles
integer
C0178602 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
Therapeutic Outcome
integer
C0087111 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Therapeutic Outcome
Code List
Therapeutic Outcome
CL Item
CR (1)
CL Item
CCR (2)
CL Item
PR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
Unknown (6)
Duration of Response
Item
Duration of Response
integer
C0237585 (UMLS CUI [1])
Item Group
Prior Radiation Therapy
C0279134 (UMLS CUI-1)
Radiation Therapy Start Date
Item
Radiation Therapy Start Date
date
C1522449 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Radiation Therapy Stop Date
Item
Radiation Therapy Stop Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Radiation Therapy Total Dose
Item
Radiation Therapy Total Dose
integer
C2919490 (UMLS CUI [1])
Radiation Therapy Location
Item
Radiation Therapy Location
text
C1522449 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Item Group
History of Lymphoma
C0024299 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Item
Stage at Diagnosis
integer
C1300072 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Stage at Diagnosis
Code List
Stage at Diagnosis
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
CL Item
IV (4)
Item
Stage at Enrollment
integer
C1300072 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
Stage at Enrollment
Code List
Stage at Enrollment
CL Item
IV (1)
Item Group
Lymphoma Cell Type
C0024299 (UMLS CUI-1)
C0449475 (UMLS CUI-2)
Item
Cell Type
integer
C0449475 (UMLS CUI [1])
Cell Type
Code List
Cell Type
CL Item
Small lymphocytic with plasmacytoid differentiation (1)
CL Item
Small lymphocytic without plasmacytoid differentiation (2)
CL Item
Follicular, small-cleaved cell (3)
CL Item
Follicular, mixed small-cleaved cell (< 50% large cell) (4)
CL Item
Follicular, large cell (5)
CL Item
Diffuse, small-cleaved (6)
CL Item
Diffuse, mixed small-cleaved & large cell (7)
CL Item
Diffuse, large cell (8)
CL Item
Large cell, immunoblastic (9)
CL Item
Lymphoblastic, convoluted (10)
CL Item
Lymphoblastic, non-convoluted (11)
CL Item
Monocytoid B-cell (12)
CL Item
Other (specify) (13)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
Specify other Cell-Type
Item
Specify other Cell-Type
text
C0449475 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Lymphoma Grade
C0024299 (UMLS CUI-1)
C0441800 (UMLS CUI-2)
Item
Lymphoma Grade
integer
C0024299 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Lymphoma Grade
Code List
Lymphoma Grade
CL Item
Low (1)
CL Item
Intermediate (2)
CL Item
High (3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
At Diagnosis (1)
CL Item
At Enrollment (2)
History of Lymphoma - Extranodal Involvement
Item
History of Lymphoma - Extranodal Involvement
text
C0024299 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3899187 (UMLS CUI [2])
Item Group
History of Lymphoma
C0024299 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
History of Lymphoma - Extranodal Involvement at Enrollment
integer
C0024299 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3899187 (UMLS CUI [2])
History of Lymphoma - Extranodal Involvement at Enrollment
Code List
History of Lymphoma - Extranodal Involvement at Enrollment
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 or more sites (3)
Item
CD20 Reactivity
integer
C0054946 (UMLS CUI [1])
CD20 Reactivity
Code List
CD20 Reactivity
CL Item
Histopathology (1)
CL Item
Flow Cytometry (2)
Date tissue obtainted (CD20 Reactivity)
Item
Date tissue obtainted (CD20 Reactivity)
date
C0475358 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0054946 (UMLS CUI [2])
Date of assay (CD20 Reactivity)
Item
Date of assay (CD20 Reactivity)
date
C0005507 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0054946 (UMLS CUI [2])
Does patient have evidence of bulky disease (> 500 gm)?
Item
Does patient have evidence of bulky disease (> 500 gm)?
boolean
C1511341 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
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