ID

38683

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 (2)
  1. 3/4/19 3/4/19 -
  2. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 30, 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

Cycle 1 Day 2 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Alias
UMLS CUI-1
C1320303
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
PK Sampling - Plasma Samples
Description

PK Sampling - Plasma Samples

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C1277698
UMLS CUI-3
C1609077
Check if Not Applicable
Description

Check if Not Applicable

Data type

integer

Alias
UMLS CUI [1]
C1272460
Date of Sampling
Description

Date of Sampling

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0870078
Time of Sampling
Description

Time of Sampling

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0870078
Check if Not Done
Description

Check if Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
SRT501 Administration
Description

SRT501 Administration

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1320722
Was SRT501 administered at this visit?
Description

Was SRT501 administered at this visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1320722
Date administered
Description

Date administered

Data type

date

Alias
UMLS CUI [1,1]
C1521801
UMLS CUI [1,2]
C0011008
Kit #
Description

Kit #

Data type

integer

Alias
UMLS CUI [1]
C2981406
Time Administered
Description

Time Administered

Data type

time

Alias
UMLS CUI [1,1]
C1521801
UMLS CUI [1,2]
C0040223
Study Treatment Compliance (Return)
Description

Study Treatment Compliance (Return)

Alias
UMLS CUI-1
C1321605
Has the subject returned their diary card?
Description

If No, please complete the comments page or the protocol deviations page.

Data type

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
Has the subject been compliant with dosing of study drug?
Description

If No, please complete the comments page or the protocol deviations page. If No, please provide the number of missed doses and the dates that the doses were missed

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
No. of missed dates:
Description

No. of missed dates:

Data type

integer

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0237753
Dates dose missed:
Description

Dates dose missed:

Data type

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705492
UMLS CUI [1,3]
C0178602
New Adverse Events and Concomitant Treatment
Description

New Adverse Events and Concomitant Treatment

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
Description

If Yes, please record details on Adverse Events page.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
Description

If Yes, please record details on Concomitant Treatment page.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0678766
UMLS CUI [2,2]
C0205217
UMLS CUI [3,1]
C0678766
UMLS CUI [3,2]
C0205216
UMLS CUI [4,1]
C0439603
UMLS CUI [4,2]
C0205217
UMLS CUI [5,1]
C0439603
UMLS CUI [5,2]
C0205216
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Similar models

Cycle 1 Day 2 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Visit Date
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
PK Sampling - Plasma Samples
C0031327 (UMLS CUI-1)
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
Item
Check if Not Applicable
integer
C1272460 (UMLS CUI [1])
Check if Not Applicable
Code List
Check if Not Applicable
CL Item
Not Applicable (1)
Date of Sampling
Item
Date of Sampling
date
C0011008 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Time of Sampling
Item
Time of Sampling
time
C0040223 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Item
Check if Not Done
integer
C1272696 (UMLS CUI [1])
Position
Code List
Check if Not Done
CL Item
Not Done (1)
Item Group
SRT501 Administration
C0304229 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Was SRT501 administered at this visit?
Item
Was SRT501 administered at this visit?
boolean
C0304229 (UMLS CUI [1,1])
C1320722 (UMLS CUI [1,2])
Date administered
Item
Date administered
date
C1521801 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Kit #
Item
Kit #
integer
C2981406 (UMLS CUI [1])
Time Administered
Item
Time Administered
time
C1521801 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Study Treatment Compliance (Return)
C1321605 (UMLS CUI-1)
Has the subject been issued with a diary card?
Item
Has the subject returned their diary card?
boolean
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
Item
Has the subject been compliant with dosing of study drug?
boolean
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
No. of missed dates:
Item
No. of missed dates:
integer
C1705492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Dates dose missed:
Item
Dates dose missed:
text
C0011008 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
New Adverse Events and Concomitant Treatment
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
Item
Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
boolean
C2347852 (UMLS CUI [1])
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
Item
Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
boolean
C2347852 (UMLS CUI [1])
C0678766 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0205216 (UMLS CUI [3,2])
C0439603 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C0439603 (UMLS CUI [5,1])
C0205216 (UMLS CUI [5,2])
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