ID

42093

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. 07.04.21 07.04.21 -
  2. 07.04.21 07.04.21 -
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GlaxoSmithKline

Hochgeladen am

7. April 2021

DOI

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

Englisch

Long-Term Follow-Up for Survival and Disease Status

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beschreibung

Site Number

Datentyp

text

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
Long-Term Follow-Up for Survival and Disease Status
Beschreibung

Long-Term Follow-Up for Survival and Disease Status

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

Patient status

Datentyp

integer

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

How was contact made?

Datentyp

integer

Alias
UMLS CUI [1]
C1705415
Specify other contact
Beschreibung

Specify other contact

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

If Yes, please complete Response Assessment formsif applicable.

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, has any of the following occured?
Beschreibung

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?
Beschreibung

If Yes, please specify below and provide applicable data

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1706712
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
C3872643
Subsequent NHL Therapy since last LTFU
Beschreibung

Subsequent NHL Therapy since last LTFU

Datentyp

text

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

NHL Therapy Start Date

Datentyp

date

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

NHL Therapy Stop Date

Datentyp

date

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

NHL Therapy total number of Cycles

Datentyp

integer

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

Myelodysplasia

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

Has the patient had a documented new diagnosis of myelodysplasia?

Datentyp

boolean

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

(Complete both AE & SAE CRFs)

Datentyp

date

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

(Complete both AE & SAE CRFs)

Datentyp

boolean

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

If yes, date of diagnosis (AML)

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 new diagnosis of another malignancy?
Beschreibung

(Complete both AE & SAE CRFs)

Datentyp

boolean

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

If yes, date of diagnosis (another malignancy)

Datentyp

date

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

Type of malignancy

Datentyp

text

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

Thyroid medication

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

TSH Date

Datentyp

date

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

TSH Result

Datentyp

float

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

TSH not done

Datentyp

integer

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

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

Datentyp

boolean

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

Start date (thyroid medication)

Datentyp

date

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

If Yes, drug name (thyroid medication)

Datentyp

text

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

HAMA

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

If yes, attach copy of lab report to CRF

Datentyp

text

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

If yes, enter accesssion Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1514821
UMLS CUI [1,2]
C0237753
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
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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
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])
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