ID

42022

Beschreibung

https://clinicaltrials.gov/show/NCT00989664 Patient Withdrawal from Study, Long Term Follow-Up for Survival & Disease Status and Notification of Patient Death Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Link

https://clinicaltrials.gov/show/NCT00989664

Stichworte

Versionen (2)
  1. 25.05.18 25.05.18 -
  2. 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

15. März 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

Englisch

Patient Withdrawal from Study, Long Term Follow-Up for Survival & Disease Status and Notification of Patient Death

1 Formulare  
Patient Withdrawal from Study
Beschreibung

Patient Withdrawal from Study

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

Withdrawal date

Datentyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Reason for withdrawal from study (check primary reason only)
Beschreibung

Reason for withdrawal from study

Datentyp

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Explanation of withdrawal (when appropriate)
Beschreibung

Explanation of withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0681841
Long Term Follow-Up for Survival & Disease Status
Beschreibung

Long Term Follow-Up for Survival & Disease Status

Alias
UMLS CUI-1
C1517942
Date of status
Beschreibung

Date of status

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0449437
Patient status:
Beschreibung

Patient status

Datentyp

integer

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

Way of contact

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705415
UMLS CUI [1,2]
C0337611
Other way of contact
Beschreibung

Other way of contact

Datentyp

text

Alias
UMLS CUI [1,1]
C1705415
UMLS CUI [1,2]
C0337611
Does the patient have an ongoing response to lodine-131 Tositumomab?
Beschreibung

(If yes, please complete Response Assessment Forms if applicable.)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0768182
UMLS CUI [1,2]
C0521982
Has any additional therapy for NHL been administered?
Beschreibung

Since the time the last LTFU was completed, has any of the following occured: (If yes, specify below and provide applicable data)

Datentyp

boolean

Alias
UMLS CUI [1]
C1706712
Has the patient had a documented diagnosis of myelodysplasia?
Beschreibung

Myelodysplasia

Datentyp

boolean

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

(complete both AE & SAE CRFs)

Datentyp

date

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

AML

Datentyp

boolean

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

(complete both AE & SAE CRFs)

Datentyp

date

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

Other malignancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
If yes, date of diagnosis:
Beschreibung

(complete both AE & SAE CRFs)

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0205394
Type of malignancy:
Beschreibung

Type of malignancy

Datentyp

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332307
Subsequent NHL Therapy since last LTFU
Beschreibung

Subsequent NHL Therapy since last LTFU

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Subsequent NHL Therapy since last LTFU
Beschreibung

Subsequent NHL Therapy since last LTFU

Datentyp

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
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
Total # of Cycles
Beschreibung

Total # of Cycles

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1302181
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
TSH Date
Beschreibung

TSH Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0040160
UMLS CUI [1,2]
C0011008
Result:
Beschreibung

TSH Result

Datentyp

float

Maßeinheiten
  • 𝞵IU/mL
Alias
UMLS CUI [1,1]
C0202230
UMLS CUI [1,2]
C1274040
𝞵IU/mL
Has the patient begun thyroid replacement therapy since the last LTFU?
Beschreibung

Thyroid replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C2242640
If yes, start date:
Beschreibung

Therapy start date

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Drug Name:
Beschreibung

Drug Name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Was a HAMA obtained since the last LTFU?
Beschreibung

HAMA

Datentyp

integer

Alias
UMLS CUI [1]
C1291910
If yes, enter accession #
Beschreibung

Accession #

Datentyp

integer

Alias
UMLS CUI [1,1]
C1510755
UMLS CUI [1,2]
C2826726
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature:
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Notification of death
Beschreibung

Notification of death

Alias
UMLS CUI-1
C0422202
UMLS CUI-2
C0007465
Cause of death (check one)
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C0007465
Other Cause of Death:
Beschreibung

Other Cause of Death

Datentyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C1521902
Relationship of study drug to patient's death (check one)
Beschreibung

Relationship of study drug to patient's death

Datentyp

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0304229
Source of Information concerning death of patient
Beschreibung

Source of Information concerning death of patient

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0011065
UMLS CUI [1,3]
C0449416
Other Source of Information concerning death of patient
Beschreibung

Other Source

Datentyp

text

Alias
UMLS CUI [1,1]
C0683836
UMLS CUI [1,2]
C0011065
UMLS CUI [1,3]
C0205394
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Ähnliche Modelle

Patient Withdrawal from Study, Long Term Follow-Up for Survival & Disease Status and Notification of Patient Death

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Withdrawal from Study
C0422727 (UMLS CUI-1)
Withdrawal date
Item
Date of wlthdrawal from study
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for withdrawal from study (check primary reason only)
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for withdrawal from study
Code List
Reason for withdrawal from study (check primary reason only)
CL Item
Patient was lost to follow-up (explain below). (1)
CL Item
Patient wished to withdraw from study (explain below). (2)
CL Item
Patient received alternative therapy (explain below). (3)
CL Item
Patient had progressive disease. (4)
CL Item
Patient died (complete Form 39). (5)
CL Item
Other (specify) (6)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Explanation of withdrawal
Item
Explanation of withdrawal (when appropriate)
text
C2349954 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
Item Group
Long Term Follow-Up for Survival & Disease Status
C1517942 (UMLS CUI-1)
Date of status
Item
Date of status
date
C0011008 (UMLS CUI [1,1])
C0449437 (UMLS CUI [1,2])
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 [1,1])
C0337611 (UMLS CUI [1,2])
Way of contact
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)
Other way of contact
Item
Other way of contact
text
C1705415 (UMLS CUI [1,1])
C0337611 (UMLS CUI [1,2])
Response to lodine-131 Tositumomab
Item
Does the patient have an ongoing response to lodine-131 Tositumomab?
boolean
C0768182 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Additional Therapy
Item
Has any additional therapy for NHL been administered?
boolean
C1706712 (UMLS CUI [1])
Myelodysplasia
Item
Has the patient had a documented diagnosis of myelodysplasia?
boolean
C0026985 (UMLS CUI [1])
Myelodysplasia diagnosis date
Item
If yes, date of diagnosis:
date
C2316983 (UMLS CUI [1,1])
C0026985 (UMLS CUI [1,2])
AML
Item
Has the patient had a documented diagnosis of AML?
boolean
C0023467 (UMLS CUI [1])
AML diagnosis date
Item
If yes, date of diagnosis:
date
C2316983 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Other malignancy
Item
Has the patient had a diagnosis of another malignancy?
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other malignancy diagnosis date
Item
If yes, date of diagnosis:
date
C2316983 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Type of malignancy
Item
Type of malignancy:
text
C0006826 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Subsequent NHL Therapy since last LTFU
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Subsequent NHL Therapy since last LTFU
Item
Subsequent NHL Therapy since last LTFU
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Therapy Start date
Item
Therapy Start date
date
C3173309 (UMLS CUI [1])
Therapy Stop Date
Item
Therapy Stop Date
date
C1531784 (UMLS CUI [1])
Total # of Cycles
Item
Total # of Cycles
integer
C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
TSH Date
Item
TSH Date
date
C0040160 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TSH Result
Item
Result:
float
C0202230 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Thyroid replacement therapy
Item
Has the patient begun thyroid replacement therapy since the last LTFU?
boolean
C2242640 (UMLS CUI [1])
Therapy start date
Item
If yes, start date:
date
C3173309 (UMLS CUI [1])
Drug Name
Item
Drug Name:
text
C0013227 (UMLS CUI [1])
Item
Was a HAMA obtained since the last LTFU?
integer
C1291910 (UMLS CUI [1])
HAMA
Code List
Was a HAMA obtained since the last LTFU?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Accession #
Item
If yes, enter accession #
integer
C1510755 (UMLS CUI [1,1])
C2826726 (UMLS CUI [1,2])
Item Group
Administration
C1320722 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Notification of death
C0422202 (UMLS CUI-1)
C0007465 (UMLS CUI-2)
Item
Cause of death (check one)
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Cause of death (check one)
CL Item
Progression of lymphoma (1)
CL Item
Complications related to drug (complete Adverse Experiences form) (2)
CL Item
Other (specify) (3)
Other Cause of Death
Item
Other Cause of Death:
text
C0007465 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Relationship of study drug to patient's death (check one)
integer
C0007465 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Relationship of study drug to patient's death
Code List
Relationship of study drug to patient's death (check one)
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
C0030705 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C0449416 (UMLS CUI [1,3])
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)
Other Source
Item
Other Source of Information concerning death of patient
text
C0683836 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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