ID

42090

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

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  1. 01.04.21 01.04.21 -
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GlaxoSmithKline

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1. April 2021

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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; Patient Withdrawal from Study; Notification of Patient Death; Clarification Form

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
Date last known alive
Beschreibung

Date last known alive

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0038952
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
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 Anti-B1 Antibody?
Beschreibung

If Yes, please complete Response Evaluation forms.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0521982
UMLS CUI [1,3]
C0549178
Has additional therapy been given for NHL since Anti-B1?
Beschreibung

If Yes, please specify therapy and start date(s) and number of cycles in "Comments" section at bottom of page)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1706712
UMLS CUI [2]
C0768182
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

If yes, date of diagnosis (myelodysplasia)

Datentyp

date

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C2316983
Has the patient had a new diagnosis of another malignancy?
Beschreibung

Has the patient had a new diagnosis of another malignancy?

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
Is the patient taking thyroid medication?
Beschreibung

Is the patient taking thyroid medication?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0013227
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
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
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Signature of Investigator
Beschreibung

Signature of Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Signature of Investigator Date
Beschreibung

Signature of Investigator Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Patient Withdrawal from Study
Beschreibung

Patient Withdrawal from Study

Alias
UMLS CUI-1
C0422727
Date of withdrawal from study
Beschreibung

Date of withdrawal from study

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0011008
Reason for withdrawal from study
Beschreibung

Check primary reason only

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify other reason for withdrawal from study
Beschreibung

Specify other reason for withdrawal from study

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Explanation of withdrawal (when appropriate)
Beschreibung

Explanation of withdrawal (when appropriate)

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0681841
Notification of Patient Death
Beschreibung

Notification of Patient Death

Alias
UMLS CUI-1
C0422202
UMLS CUI-2
C0011065
Date of death
Beschreibung

Date of death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Cause of death
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1]
C0007465
Specify other cause of death
Beschreibung

Specify other cause of death

Datentyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C2348235
If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded
Beschreibung

If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded

Datentyp

text

Alias
UMLS CUI [1]
C0007465
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0009566
UMLS CUI [2,3]
C0869014
UMLS CUI [3]
C0678257
Relationship of study drug to patient's death
Beschreibung

Relationship of study drug to patient's death

Datentyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011065
UMLS CUI [1,3]
C0439849
Source of information concerning death of patient
Beschreibung

Check allt hat apply

Datentyp

integer

Alias
UMLS CUI [1]
C0011065
UMLS CUI [2]
C0683836
Specify other source of information concerning death of patient
Beschreibung

Specify other source of information concerning death of patient

Datentyp

text

Alias
UMLS CUI [1]
C0011065
UMLS CUI [2]
C0683836
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
Clarification Form
Beschreibung

Clarification Form

Alias
UMLS CUI-1
C2986669
Form Number
Beschreibung

Form Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301746
UMLS CUI [1,2]
C0237753
Series Page Number
Beschreibung

Series Page Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C0237753
Comments
Beschreibung

Clearly identify the item to which the comment applies (e.g. date, time, etc.)

Datentyp

text

Alias
UMLS CUI [1]
C0947611
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Ähnliche Modelle

Long-Term Follow-Up for Survival and Disease Status; Patient Withdrawal from Study; Notification of Patient Death; Clarification Form

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)
Date last known alive
Item
Date last known alive
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
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 Anti-B1 Antibody?
Item
Does the patient have an ongoing response to Iodine-131 Anti-B1 Antibody?
boolean
C0768182 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Has additional therapy been given for NHL since Anti-B1?
Item
Has additional therapy been given for NHL since Anti-B1?
boolean
C0024305 (UMLS CUI [1,1])
C1706712 (UMLS CUI [1,2])
C0768182 (UMLS CUI [2])
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 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])
Is the patient taking thyroid medication?
Item
Is the patient taking thyroid medication?
boolean
C0040128 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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])
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])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Signature of Investigator
Item
Signature of Investigator
text
C2346576 (UMLS CUI [1])
Signature of Investigator Date
Item
Signature of Investigator Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Patient Withdrawal from Study
C0422727 (UMLS CUI-1)
Date of withdrawal from study
Item
Date of withdrawal from study
date
C0422727 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for withdrawal from study
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for withdrawal from study
Code List
Reason for withdrawal from study
CL Item
Patient was lost to follow-up (explain below) (4)
CL Item
Patient wished to withdraw from study (explain below) (5)
CL Item
Patient received alternative therapy (explain below) (7)
CL Item
Patient had progressive disease (9)
CL Item
Patient died (complete "Notification of Patient Death" form) (10)
CL Item
Other (specify) (99)
Specify other reason for withdrawal from study
Item
Specify other reason for withdrawal from study
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Explanation of withdrawal (when appropriate)
Item
Explanation of withdrawal (when appropriate)
text
C2349954 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
Item Group
Notification of Patient Death
C0422202 (UMLS CUI-1)
C0011065 (UMLS CUI-2)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Cause of death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Cause of death
CL Item
Progression of lymphoma (1)
CL Item
Complications related to drug (complete Adverse Experiences form) (2)
CL Item
Other (specify) (3)
Specify other cause of death
Item
Specify other cause of death
text
C0007465 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded
Item
If cause of death was related to complications of treatment, please describe or reference forms on which information is recorded
text
C0007465 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0869014 (UMLS CUI [2,3])
C0678257 (UMLS CUI [3])
Item
Relationship of study drug to patient's death
integer
C0304229 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship of study drug to patient's death
Code List
Relationship of study drug to patient's death
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
Item
Source of information concerning death of patient
integer
C0011065 (UMLS CUI [1])
C0683836 (UMLS CUI [2])
Source of information concerning death of patient
Code List
Source of information concerning death of patient
CL Item
Hospital physician (1)
CL Item
Patient's physician (2)
CL Item
Family (3)
CL Item
Newspaper (obituary) (4)
CL Item
Tumor registry (5)
CL Item
Other (specify) (6)
Specify other source of information concerning death of patient
Item
Specify other source of information concerning death of patient
text
C0011065 (UMLS CUI [1])
C0683836 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item Group
Clarification Form
C2986669 (UMLS CUI-1)
Form Number
Item
Form Number
integer
C1301746 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Series Page Number
Item
Series Page Number
integer
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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