ID

35310

Beschreibung

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

Stichworte

  1. 27.02.19 27.02.19 -
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GlaxoSmithKline

Hochgeladen am

27. Februar 2019

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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

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

Adminstrative
Beschreibung

Adminstrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

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

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?
Beschreibung

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)

Datentyp

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
Beschreibung

Medical and Surgical History

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

Seq #

Datentyp

integer

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

Description of medical condition or abnormality

Datentyp

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
Beschreibung

Year of first diagnosis

Datentyp

partialDate

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

Ongoing

Datentyp

boolean

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

Currently being treated with Concomitant Medication?

Datentyp

boolean

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

Disease Stage at Study Entry

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

If Yes, complete below

Datentyp

boolean

Alias
UMLS CUI [1]
C0699749
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Stage
Beschreibung

Check one box only

Datentyp

integer

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

Classification of Disease at Study Entry

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

If Yes, complete below

Datentyp

boolean

Alias
UMLS CUI [1]
C0683326
Disease Classification
Beschreibung

Check one box only

Datentyp

integer

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

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?
Beschreibung

Did the subject have previous cancer related surgical history?

Datentyp

boolean

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

Cancer related Surgical History

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

Seq #

Datentyp

integer

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

Surgery Description (ex. Mastectomy, right breast)

Datentyp

text

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

Surgery Date

Datentyp

date

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

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?
Beschreibung

If Yes, complete below

Datentyp

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
Beschreibung

Last Previous Anti-Neoplastic Therapy page

Datentyp

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
Beschreibung

Previous Anti-Neoplastic Therapy

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

Seq #

Datentyp

integer

Alias
UMLS CUI [1]
C0237753
Type of Therapy
Beschreibung

Type of Therapy

Datentyp

integer

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

If other Type of Therapy, please specify

Datentyp

text

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

Treatment

Datentyp

text

Alias
UMLS CUI [1]
C0087111
Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1]
C3146298
Date First Dose
Beschreibung

Date First Dose

Datentyp

date

Alias
UMLS CUI [1]
C3173309
Date Last Dose
Beschreibung

Date Last Dose

Datentyp

date

Alias
UMLS CUI [1]
C1762893
Best Response
Beschreibung

Best Response

Datentyp

integer

Alias
UMLS CUI [1]
C2986560

Ähnliche Modelle

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

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
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])
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])
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])
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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