ID

42093

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2021-04-07 2021-04-07 -
  2. 2021-04-07 2021-04-07 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

7 april 2021

DOI

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Creative Commons BY 4.0
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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

Engelsk

Long-Term Follow-Up for Survival and Disease Status

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beskrivning

Site Number

Datatyp

text

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

Patient Number

Datatyp

text

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

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Long-Term Follow-Up for Survival and Disease Status
Beskrivning

Long-Term Follow-Up for Survival and Disease Status

Alias
UMLS CUI-1
C1517942
UMLS CUI-2
C1148433
UMLS CUI-3
C0699749
Patient status
Beskrivning

Patient status

Datatyp

integer

Alias
UMLS CUI [1]
C0449437
How was contact made?
Beskrivning

How was contact made?

Datatyp

integer

Alias
UMLS CUI [1]
C1705415
Specify other contact
Beskrivning

Specify other contact

Datatyp

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?
Beskrivning

If Yes, please complete Response Assessment formsif applicable.

Datatyp

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, has any of the following occured?
Beskrivning

Since the time the last LTFU was completed, has any of the following occured?

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

If Yes, please specify below and provide applicable data

Datatyp

boolean

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

Subsequent NHL Therapy since last LTFU

Alias
UMLS CUI-1
C0024305
UMLS CUI-2
C0087111
UMLS CUI-3
C3872643
Subsequent NHL Therapy since last LTFU
Beskrivning

Subsequent NHL Therapy since last LTFU

Datatyp

text

Alias
UMLS CUI [1]
C0024305
UMLS CUI [2]
C0087111
UMLS CUI [3]
C3872643
NHL Therapy Start Date
Beskrivning

NHL Therapy Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0808070
NHL Therapy Stop Date
Beskrivning

NHL Therapy Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0806020
NHL Therapy total number of Cycles
Beskrivning

NHL Therapy total number of Cycles

Datatyp

integer

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C1511572
UMLS CUI [2,2]
C0750480
Myelodysplasia
Beskrivning

Myelodysplasia

Alias
UMLS CUI-1
C0026985
Has the patient had a documented new diagnosis of myelodysplasia?
Beskrivning

Has the patient had a documented new diagnosis of myelodysplasia?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C0011900
If yes, date of diagnosis (myelodysplasia)
Beskrivning

(Complete both AE & SAE CRFs)

Datatyp

date

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

(Complete both AE & SAE CRFs)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0011900
If yes, date of diagnosis (AML)
Beskrivning

If yes, date of diagnosis (AML)

Datatyp

date

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

Another malignancy

Alias
UMLS CUI-1
C0006826
Has the patient had a new diagnosis of another malignancy?
Beskrivning

(Complete both AE & SAE CRFs)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0011900
If yes, date of diagnosis (another malignancy)
Beskrivning

If yes, date of diagnosis (another malignancy)

Datatyp

date

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2316983
Type of malignancy
Beskrivning

Type of malignancy

Datatyp

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
Thyroid medication
Beskrivning

Thyroid medication

Alias
UMLS CUI-1
C0040128
UMLS CUI-2
C0013227
TSH Date
Beskrivning

TSH Date

Datatyp

date

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

TSH Result

Datatyp

float

Måttenheter
  • uIU/mL
Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1274040
uIU/mL
TSH not done
Beskrivning

TSH not done

Datatyp

integer

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

(If yes, complete both AE & Concomitant Medication CRFs)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2242640
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C3872643
Start date (thyroid medication)
Beskrivning

Start date (thyroid medication)

Datatyp

date

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
If Yes, drug name (thyroid medication)
Beskrivning

If Yes, drug name (thyroid medication)

Datatyp

text

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2360065
HAMA
Beskrivning

HAMA

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

If yes, attach copy of lab report to CRF

Datatyp

text

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C3872643
If yes, enter accesssion Number
Beskrivning

If yes, enter accesssion Number

Datatyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
Investigator Signature
Beskrivning

Investigator Signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature date
Beskrivning

Investigator Signature date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Long-Term Follow-Up for Survival and Disease Status

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
text
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
Long-Term Follow-Up for Survival and Disease Status
C1517942 (UMLS CUI-1)
C1148433 (UMLS CUI-2)
C0699749 (UMLS CUI-3)
Item
Patient status
integer
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)
Item
How was contact made?
integer
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, specify (5)
Specify other contact
Item
Specify other contact
text
C1705415 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Does the patient have an ongoing response to Iodine-131 Tositumomab?
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, has any of the following occured?
C1517942 (UMLS CUI-1)
C3872643 (UMLS CUI-2)
Has any additional therapy for NHL been administered?
Item
Has any additional therapy for NHL been administered?
boolean
C0024305 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
Item Group
Subsequent NHL Therapy since last LTFU
C0024305 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C3872643 (UMLS CUI-3)
Subsequent NHL Therapy since last LTFU
Item
Subsequent NHL Therapy since last LTFU
text
C0024305 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C3872643 (UMLS CUI [3])
NHL Therapy Start Date
Item
NHL Therapy Start Date
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
NHL Therapy Stop Date
Item
NHL Therapy Stop Date
date
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
NHL Therapy total number of Cycles
Item
NHL Therapy total number of Cycles
integer
C0024305 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1511572 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
Item Group
Myelodysplasia
C0026985 (UMLS CUI-1)
Has the patient had a documented new diagnosis of myelodysplasia?
Item
Has the patient had a documented new diagnosis of myelodysplasia?
boolean
C0026985 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
If yes, date of diagnosis (myelodysplasia)
Item
If yes, date of diagnosis (myelodysplasia)
date
C0026985 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Has the patient had a documented diagnosis of AML?
Item
Has the patient had a documented diagnosis of AML?
boolean
C0023467 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
If yes, date of diagnosis (AML)
Item
If yes, date of diagnosis (AML)
date
C0023467 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item Group
Another malignancy
C0006826 (UMLS CUI-1)
Has the patient had a new diagnosis of another malignancy?
Item
Has the patient had a new diagnosis of another malignancy?
boolean
C0006826 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
If yes, date of diagnosis (another malignancy)
Item
If yes, date of diagnosis (another malignancy)
date
C0006826 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Type of malignancy
Item
Type of malignancy
text
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Thyroid medication
C0040128 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
TSH Date
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
integer
C0202230 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
TSH not done
Code List
TSH not done
CL Item
Not Done (1)
Has the patient begun thyroid replacement therapy since last LTFU?
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])
Start date (thyroid medication)
Item
Start date (thyroid medication)
date
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
If Yes, drug name (thyroid medication)
Item
If Yes, drug name (thyroid medication)
text
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Item Group
HAMA
C1291910 (UMLS CUI-1)
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])
Was a HAMA obtained since the last LTFU?
Code List
Was a HAMA obtained since the last LTFU?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (NA)
If yes, enter accesssion Number
Item
If yes, enter accesssion Number
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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])
Tillbaka till toppen 

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