ID

42022

Description

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

Keywords

  1. 5/25/18 5/25/18 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY-NC 3.0

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Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664

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

Patient Withdrawal from Study
Description

Patient Withdrawal from Study

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

Withdrawal date

Data type

date

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

Reason for withdrawal from study

Data type

integer

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

Date of last contact

Data type

date

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

Explanation of withdrawal

Data type

text

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

Long Term Follow-Up for Survival & Disease Status

Alias
UMLS CUI-1
C1517942
Date of status
Description

Date of status

Data type

date

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

Patient status

Data type

integer

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

Way of contact

Data type

integer

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

Other way of contact

Data type

text

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

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

Data type

boolean

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

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

Data type

boolean

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

Myelodysplasia

Data type

boolean

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

(complete both AE & SAE CRFs)

Data type

date

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

AML

Data type

boolean

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

(complete both AE & SAE CRFs)

Data type

date

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

Other malignancy

Data type

boolean

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

(complete both AE & SAE CRFs)

Data type

date

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

Type of malignancy

Data type

text

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

Subsequent NHL Therapy since last LTFU

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

Subsequent NHL Therapy since last LTFU

Data type

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
Therapy Start date
Description

Therapy Start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Therapy Stop Date
Description

Therapy Stop Date

Data type

date

Alias
UMLS CUI [1]
C1531784
Total # of Cycles
Description

Total # of Cycles

Data type

integer

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

Laboratory tests

Alias
UMLS CUI-1
C0022885
TSH Date
Description

TSH Date

Data type

date

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

TSH Result

Data type

float

Measurement units
  • 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?
Description

Thyroid replacement therapy

Data type

boolean

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

Therapy start date

Data type

date

Alias
UMLS CUI [1]
C3173309
Drug Name:
Description

Drug Name

Data type

text

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

HAMA

Data type

integer

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

Accession #

Data type

integer

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

Administration

Alias
UMLS CUI-1
C1320722
Investigator Signature:
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

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

Notification of death

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

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

Data type

integer

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

Other Cause of Death

Data type

text

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

Relationship of study drug to patient's death

Data type

integer

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

Source of Information concerning death of patient

Data type

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
Description

Other Source

Data type

text

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

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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])
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])
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])
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])
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])
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])
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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