ID

35369

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. 3/3/19 3/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 3, 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 1 (Post Dose) - Vital Signs; PK Sampling - Plasma Samples; Study Treatment Compliance (Issue); 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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Were vital signs assessed?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1516048
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Position
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C1262869
Systolic BP
Description

Systolic BP

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Description

Diastolic BP

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration Rate
Description

Respiration Rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Description

Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Height
Description

Height

Data type

float

Alias
UMLS CUI [1]
C0005890
Height Unit
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0439148
Weight
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Weight Unit
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439148
PK Sampling - Plasma Samples
Description

PK Sampling - Plasma Samples

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C1277698
UMLS CUI-3
C1609077
Time Point
Description

Time points are relative to study drug administration. Any deviations in the times of collection should be recorded on the comments page or the protocol deviations page.

Data type

integer

Alias
UMLS CUI [1]
C0040223
Date of Sampling
Description

Date of Sampling

Data type

date

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

Time of Sampling

Data type

time

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

Check if Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
Study Treatment Compliance (Issue)
Description

Study Treatment Compliance (Issue)

Alias
UMLS CUI-1
C0949266
UMLS CUI-2
C1321605
Has the subject been issued with a diary card?
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C3890583
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2698559
Has the subject refrained from ingesting large quantities of resveratrol containing food and drink such as peanuts, grapes, mulberries and alcohol within 48 hours of dosing on scheduled PK collection days? (Only applicable to PK subjects)
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0750563
UMLS CUI [1,2]
C0683176
UMLS CUI [1,3]
C0073096
UMLS CUI [2]
C0458244
UMLS CUI [3]
C0949399
UMLS CUI [4]
C0018208
UMLS CUI [5]
C0453284
UMLS CUI [6]
C0001948
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]
C0877248
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]
C0178602
UMLS CUI [2,2]
C0205217
UMLS CUI [3,1]
C0178602
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 1 (Post Dose) - Vital Signs; PK Sampling - Plasma Samples; Study Treatment Compliance (Issue); 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
Vital Signs
C0518766 (UMLS CUI-1)
Were vital signs assessed?
Item
Were vital signs assessed?
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item
Position
integer
C1262869 (UMLS CUI [1])
Position
Code List
Position
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Systolic BP
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
Diastolic BP
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiration Rate
Item
Respiration Rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Temperature Unit
Code List
Temperature Unit
CL Item
°C (1)
CL Item
°F (2)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Height Unit
integer
C0005890 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Height Unit
Code List
Height Unit
CL Item
cm (1)
CL Item
in (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight Unit
integer
C0005910 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Weight Unit
Code List
Weight Unit
CL Item
kg (1)
CL Item
lb (2)
Item Group
PK Sampling - Plasma Samples
C0031327 (UMLS CUI-1)
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
Item
Time Point
integer
C0040223 (UMLS CUI [1])
Time Point
Code List
Time Point
CL Item
30min (1)
CL Item
1hr (2)
CL Item
2hr (3)
CL Item
4hr (4)
CL Item
6hr (5)
Date of Sampling
Item
Date of Sampling
date
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Sampling
Item
Time of Sampling
time
C0870078 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Check if Not Done
integer
C1272696 (UMLS CUI [1])
Check if Not Done
Code List
Check if Not Done
CL Item
Not Done (1)
Item Group
Study Treatment Compliance (Issue)
C0949266 (UMLS CUI-1)
C1321605 (UMLS CUI-2)
Has the subject been issued with a diary card?
Item
Has the subject been issued with a diary card?
boolean
C3890583 (UMLS CUI [1])
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
Item
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
boolean
C0304229 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
Item
Has the subject refrained from ingesting large quantities of resveratrol containing food and drink such as peanuts, grapes, mulberries and alcohol within 48 hours of dosing on scheduled PK collection days? (Only applicable to PK subjects)
integer
C0750563 (UMLS CUI [1,1])
C0683176 (UMLS CUI [1,2])
C0073096 (UMLS CUI [1,3])
C0458244 (UMLS CUI [2])
C0949399 (UMLS CUI [3])
C0018208 (UMLS CUI [4])
C0453284 (UMLS CUI [5])
C0001948 (UMLS CUI [6])
Has the subject refrained from ingesting large quantities of resveratrol
Code List
Has the subject refrained from ingesting large quantities of resveratrol containing food and drink such as peanuts, grapes, mulberries and alcohol within 48 hours of dosing on scheduled PK collection days? (Only applicable to PK subjects)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (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
C0877248 (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])
C0178602 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0178602 (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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