ID

35568

Beschrijving

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

Trefwoorden

Versies (3)
  1. 07-03-19 07-03-19 -
  2. 10-03-19 10-03-19 -
  3. 10-03-19 10-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

10 maart 2019

DOI

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Licentie

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

Engels

SRT501 + Bortezomib Cycle __ Day 4 (Post Dose) - Vital Signs; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beschrijving

Vital Signs

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

If Yes, complete below

Datatype

boolean

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

Date of assessment

Datatype

date

Alias
UMLS CUI [1]
C2985720
Position
Beschrijving

Check one box only

Datatype

integer

Alias
UMLS CUI [1]
C1262869
Systolic BP
Beschrijving

Systolic BP

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Beschrijving

Diastolic BP

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration Rate
Beschrijving

Respiration Rate

Datatype

integer

Maateenheden
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beschrijving

Temperature

Datatype

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Beschrijving

Check one box only

Datatype

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Weight
Beschrijving

Weight

Datatype

float

Alias
UMLS CUI [1]
C0005910
Weight Unit
Beschrijving

Check one box only

Datatype

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439148
SRT501 Administration
Beschrijving

SRT501 Administration

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

Was SRT501 administered at this visit?

Datatype

boolean

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

Date administered

Datatype

date

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

Kit #

Datatype

integer

Alias
UMLS CUI [1]
C2981406
Time Administered
Beschrijving

Time Administered

Datatype

time

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

Study Treatment Compliance (Return)

Alias
UMLS CUI-1
C1321605
UMLS CUI-2
C0332156
Has the subject returned their diary card?
Beschrijving

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

Datatype

boolean

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

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

Datatype

boolean

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

No. of missed dates:

Datatype

integer

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

Dates dose missed:

Datatype

text

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

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?
Beschrijving

If Yes, please record details on Adverse Events page.

Datatype

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?
Beschrijving

If Yes, please record details on Concomitant Treatment page.

Datatype

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

SRT501 + Bortezomib Cycle __ Day 4 (Post Dose) - Vital Signs; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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
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)
C0332156 (UMLS CUI-2)
Has the subject returned their diary card?
Item
Has the subject returned their diary card?
boolean
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
Has the subject been compliant with dosing of study drug?
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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