ID

35310

Description

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Keywords

Versions (1)
  1. 2/27/19 2/27/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 27, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

English

Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

1 forms  
Adminstrative
Description

Adminstrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Does the subject have any clinically significant medical or surgical history?
Description

Does the subject have any clinically significant medical or surgical history?

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C2826293
UMLS CUI-3
C0489540
UMLS CUI-4
C2826293
Does the subject have any clinically significant medical or surgical history?
Description

If yes, please record details below (please record any new medical conditions occurring after the signing of the Informed Consent Form on the Adverse Events page)

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0489540
UMLS CUI [1,4]
C2826293
Medical and Surgical History
Description

Medical and Surgical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Seq #
Description

Seq #

Data type

integer

Alias
UMLS CUI [1]
C0237753
Description of medical condition or abnormality
Description

Description of medical condition or abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0678257
Year of first diagnosis
Description

Year of first diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Ongoing
Description

Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Currently being treated with Concomitant Medication?
Description

Currently being treated with Concomitant Medication?

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Disease Stage at Study Entry
Description

Disease Stage at Study Entry

Alias
UMLS CUI-1
C0699749
UMLS CUI-2
C0008976
UMLS CUI-3
C1301880
Was Disease Stage assessed?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1]
C0699749
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Stage
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C0699749
Classification of Disease at Study Entry
Description

Classification of Disease at Study Entry

Alias
UMLS CUI-1
C0683326
UMLS CUI-2
C0008976
UMLS CUI-3
C1301880
Was Classification of Disease performed?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1]
C0683326
Disease Classification
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C0683326
Did the subject have previous cancer related surgical history?
Description

Did the subject have previous cancer related surgical history?

Alias
UMLS CUI-1
C0489540
UMLS CUI-2
C2826292
Did the subject have previous cancer related surgical history?
Description

Did the subject have previous cancer related surgical history?

Data type

boolean

Alias
UMLS CUI [1,1]
C0489540
UMLS CUI [1,2]
C2826292
Cancer related Surgical History
Description

Cancer related Surgical History

Alias
UMLS CUI-1
C0489540
UMLS CUI-2
C2826292
Seq #
Description

Seq #

Data type

integer

Alias
UMLS CUI [1]
C0237753
Surgery Description (ex. Mastectomy, right breast)
Description

Surgery Description (ex. Mastectomy, right breast)

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678257
UMLS CUI [2]
C0024881
Surgery Date
Description

Surgery Date

Data type

date

Alias
UMLS CUI [1]
C1628561
Previous Anti-Neoplastic Therapy
Description

Previous Anti-Neoplastic Therapy

Alias
UMLS CUI-1
C0003392
UMLS CUI-2
C1514463
Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C1514463
UMLS CUI [4,1]
C0281176
UMLS CUI [4,2]
C1514463
UMLS CUI [5,1]
C0017296
UMLS CUI [5,2]
C1514463
UMLS CUI [6,1]
C1515119
UMLS CUI [6,2]
C0026764
UMLS CUI [6,3]
C1514463
UMLS CUI [7,1]
C1515119
UMLS CUI [7,2]
C0006826
UMLS CUI [7,3]
C1514463
Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
Description

Last Previous Anti-Neoplastic Therapy page

Data type

integer

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C1704732
UMLS CUI [2,2]
C1517741
Previous Anti-Neoplastic Therapy
Description

Previous Anti-Neoplastic Therapy

Alias
UMLS CUI-1
C0003392
UMLS CUI-2
C1514463
Seq #
Description

Seq #

Data type

integer

Alias
UMLS CUI [1]
C0237753
Type of Therapy
Description

Type of Therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0087111
If other Type of Therapy, please specify.
Description

If other Type of Therapy, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Treatment
Description

Treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Date First Dose
Description

Date First Dose

Data type

date

Alias
UMLS CUI [1]
C3173309
Date Last Dose
Description

Date Last Dose

Data type

date

Alias
UMLS CUI [1]
C1762893
Best Response
Description

Best Response

Data type

integer

Alias
UMLS CUI [1]
C2986560
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Similar models

Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adminstrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Does the subject have any clinically significant medical or surgical history?
C0262926 (UMLS CUI-1)
C2826293 (UMLS CUI-2)
C0489540 (UMLS CUI-3)
C2826293 (UMLS CUI-4)
Does the subject have any clinically significant medical or surgical history?
Item
Does the subject have any clinically significant medical or surgical history?
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0489540 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Item Group
Medical and Surgical History
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
Description of medical condition or abnormality
Item
Description of medical condition or abnormality
text
C0012634 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Currently being treated with Concomitant Medication?
Item
Currently being treated with Concomitant Medication?
boolean
C2347852 (UMLS CUI [1])
Item Group
Disease Stage at Study Entry
C0699749 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C1301880 (UMLS CUI-3)
Was Disease Stage assessed?
Item
Was Disease Stage assessed?
boolean
C0699749 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Stage
integer
C0699749 (UMLS CUI [1])
Stage
Code List
Stage
CL Item
1 (Durie-Salmon Criteria: All of the following: Hemoglobin value >10 g/dL; Serum calcium value normal or ≤12 mg/dL; Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only; Low M-component production rate; IgG value <5 g/dL; IgA value <3 g/dL; Bence Jones protein <4 g/24 h; ISS Criteria: ß2-M <3.5 and Albumin ≥3.5 ) (1)
CL Item
2 (Durie-Salmon Criteria: Neither stage I nor stage III; ISS Criteria: Neither stage I nor stage III) (2)
CL Item
3 (Durie-Salmon Criteria: One or more of the following: Hemoglobin value <8.5 g/dL; Serum calcium value >12 mg/dL; Advanced lytic bone lesions (scale 3); High M-component production rate; IgG value >7 g/dL; IgA value >5 g/dL; Bence Jones protein >12 g/24 h; ISS Criteria: ß2-M >5.5) (3)
Item Group
Classification of Disease at Study Entry
C0683326 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C1301880 (UMLS CUI-3)
Was Classification of Disease performed?
Item
Was Classification of Disease performed?
boolean
C0683326 (UMLS CUI [1])
Item
Disease Classification
integer
C0683326 (UMLS CUI [1])
Disease Classification
Code List
Disease Classification
CL Item
Asymptomatic Multiple Myeloma (MM)  (1)
CL Item
Symptomatic Multiple Myeloma (MM) (2)
Item Group
Did the subject have previous cancer related surgical history?
C0489540 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
Did the subject have previous cancer related surgical history?
Item
Did the subject have previous cancer related surgical history?
boolean
C0489540 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
Item Group
Cancer related Surgical History
C0489540 (UMLS CUI-1)
C2826292 (UMLS CUI-2)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
Surgery Description (ex. Mastectomy, right breast)
Item
Surgery Description (ex. Mastectomy, right breast)
text
C0543467 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
Surgery Date
Item
Surgery Date
date
C1628561 (UMLS CUI [1])
Item Group
Previous Anti-Neoplastic Therapy
C0003392 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
Item
Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
boolean
C0392920 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C0281176 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
C0017296 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C1515119 (UMLS CUI [6,1])
C0026764 (UMLS CUI [6,2])
C1514463 (UMLS CUI [6,3])
C1515119 (UMLS CUI [7,1])
C0006826 (UMLS CUI [7,2])
C1514463 (UMLS CUI [7,3])
Item
Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
integer
C0003392 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1704732 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
undefined item
Code List
Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
CL Item
Last Previous Anti-Neoplastic Therapy page (1)
Item Group
Previous Anti-Neoplastic Therapy
C0003392 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Seq #
Item
Seq #
integer
C0237753 (UMLS CUI [1])
Item
Type of Therapy
integer
C0332307 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Type of Therapy
Code List
Type of Therapy
CL Item
Chemotherapy (1)
CL Item
Hormone therapy (2)
CL Item
Immunotherapy (3)
CL Item
Antibody therapy (4)
CL Item
Gene therapy (5)
CL Item
Other, specify (6)
If other Type of Therapy, please specify
Item
If other Type of Therapy, please specify.
text
C0332307 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Treatment
Item
Treatment
text
C0087111 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Date First Dose
Item
Date First Dose
date
C3173309 (UMLS CUI [1])
Date Last Dose
Item
Date Last Dose
date
C1762893 (UMLS CUI [1])
Item
Best Response
integer
C2986560 (UMLS CUI [1])
Best Response
Code List
Best Response
CL Item
CR (1)
CL Item
PR (2)
CL Item
MR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
Unknown (6)
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