ID

35367

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

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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 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration

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
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Summary
Description

Eligibility Summary

Alias
UMLS CUI-1
C0013893
Did the subject meet all Eligibility Criteria?
Description

If No, complete below

Data type

boolean

Alias
UMLS CUI [1]
C0013893
List all Inclusion criteria subject did not meet
Description

List all Inclusion criteria subject did not meet

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
List all Exclusion criteria subject did not meet
Description

List all Exclusion criteria subject did not meet

Data type

integer

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
Was an Exemption granted?
Description

Was an Exemption granted?

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348482
Was a physical examination performed?
Description

Was a physical examination performed?

Alias
UMLS CUI-1
C0031809
Was a physical examination performed?
Description

If Yes, please complete below.

Data type

boolean

Alias
UMLS CUI [1]
C0031809
Date of Physical Examination
Description

Date of Physical Examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Clinical Assessment
Description

Clinical Assessment

Data type

integer

Alias
UMLS CUI [1]
C4534461
If other Clinical Assessment, please specify.
Description

If other Clinical Assessment, please specify

Data type

text

Alias
UMLS CUI [1,1]
C4534461
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Physical Findings
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
Please specify Abnormal conditions
Description

If clinically significant, please record on the adverse event page

Data type

text

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
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
Serum beta-hCG Pregnancy Test
Description

Serum beta-hCG Pregnancy Test

Alias
UMLS CUI-1
C0430060
Is the subject female of child-bearing potential?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1]
C1960468
Has a serum β-hCG pregnancy test been performed?
Description

If a serum β-hCG pregnancy test has been performed please give details.

Data type

boolean

Alias
UMLS CUI [1]
C0430060
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result of pregnancy test
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C0427777
PK Sampling - Plasma Samples
Description

PK Sampling - Plasma Samples

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C1277698
UMLS CUI-3
C1609077
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
SRT501 Administration
Description

SRT501 Administration

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1533734
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]
C1533734
Date administered
Description

Date administered

Data type

date

Alias
UMLS CUI [1,1]
C1533734
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]
C1533734
UMLS CUI [1,2]
C0040223
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Similar models

Cycle 1 Day 1 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration

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)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Summary
C0013893 (UMLS CUI-1)
Did the subject meet all Eligibility Criteria?
Item
Did the subject meet all Eligibility Criteria?
boolean
C0013893 (UMLS CUI [1])
List all Inclusion criteria subject did not meet
Item
List all Inclusion criteria subject did not meet
integer
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
List all Exclusion criteria subject did not meet
Item
List all Exclusion criteria subject did not meet
integer
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Was an Exemption granted?
Item
Was an Exemption granted?
boolean
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Item Group
Was a physical examination performed?
C0031809 (UMLS CUI-1)
Was a physical examination performed?
Item
Was a physical examination performed?
boolean
C0031809 (UMLS CUI [1])
Date of Physical Examination
Item
Date of Physical Examination
date
C2826643 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item
Clinical Assessment
integer
C4534461 (UMLS CUI [1])
Clinical Assessment
Code List
Clinical Assessment
CL Item
General Appearance  (1)
CL Item
Musculoskeletal  (2)
CL Item
Skin and Mucosa  (3)
CL Item
Head and Neck (4)
CL Item
Lymphatic  (5)
CL Item
Respiratory  (6)
CL Item
Breasts  (7)
CL Item
Gastrointestinal  (8)
CL Item
Cardiovascular  (9)
CL Item
Extremities  (10)
CL Item
Neurological  (11)
CL Item
Psychological  (12)
CL Item
Genitourinary  (13)
CL Item
Rectal  (14)
CL Item
Eyes,ears,nose & throat  (15)
CL Item
Other (specify) (99)
If other Clinical Assessment, please specify
Item
If other Clinical Assessment, please specify.
text
C4534461 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Physical Findings
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Physical Findings
Code List
Physical Findings
CL Item
Not Done (1)
CL Item
Normal (2)
CL Item
Abnormal (3)
Please specify Abnormal conditions
Item
Please specify Abnormal conditions
text
C0348080 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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
Serum beta-hCG Pregnancy Test
C0430060 (UMLS CUI-1)
Is the subject female of child-bearing potential?
Item
Is the subject female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Has a serum β-hCG pregnancy test been performed?
Item
Has a serum β-hCG pregnancy test been performed?
boolean
C0430060 (UMLS CUI [1])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of pregnancy test
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result of pregnancy test
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
PK Sampling - Plasma Samples
C0031327 (UMLS CUI-1)
C1277698 (UMLS CUI-2)
C1609077 (UMLS CUI-3)
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
SRT501 Administration
C0304229 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Was SRT501 administered at this visit?
Item
Was SRT501 administered at this visit?
boolean
C0304229 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Kit #
Item
Kit #
integer
C2981406 (UMLS CUI [1])
Time administered
Item
Time administered
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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