ID

35541

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. 3/7/19 3/7/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 7, 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

SRT501 + Bortezomib Cycle __ Day 4 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib 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
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
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
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
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Was sampling performed?
Description

If No, or if results are not available, please complete details on the comments page or the protocol deviations page.

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Date and time of sample
Description

Date and time of sample

Data type

datetime

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
Laboratory name:
Description

(if different from main hospital laboratory)

Data type

text

Alias
UMLS CUI [1]
C3258037
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Parameter
Description

Parameter

Data type

integer

Alias
UMLS CUI [1]
C0549193
Result
Description

Result

Data type

text

Alias
UMLS CUI [1]
C1274040
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Finding
Description

Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.

Data type

integer

Alias
UMLS CUI [1]
C0243095
Not Done
Description

Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
Clinical Chemistry, Coagulation and Electrolytes
Description

Clinical Chemistry, Coagulation and Electrolytes

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0005778
UMLS CUI-3
C0013832
Was sampling performed?
Description

If No, or if results are not available, please complete details on the comments page or the protocol deviations page.

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Date and time of sample
Description

Date and time of sample

Data type

datetime

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
Laboratory name:
Description

(if different from main hospital laboratory)

Data type

text

Alias
UMLS CUI [1]
C3258037
Clinical Chemistry, Coagulation and Electrolytes
Description

Clinical Chemistry, Coagulation and Electrolytes

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0005778
UMLS CUI-3
C0013832
Parameter
Description

Parameter

Data type

integer

Alias
UMLS CUI [1]
C0549193
Results
Description

Results

Data type

text

Alias
UMLS CUI [1]
C1254595
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Finding
Description

Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.

Data type

integer

Alias
UMLS CUI [1]
C0243095
Not Done
Description

Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
Bortezomib Administration
Description

Bortezomib Administration

Alias
UMLS CUI-1
C1176309
UMLS CUI-2
C1533734
Was bortezomib administered at this visit?
Description

Was bortezomib administered at this visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C1533734
Date administered
Description

Date administered

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Lot #
Description

Lot #

Data type

integer

Alias
UMLS CUI [1]
C1115660
Time Administered
Description

Time Administered

Data type

time

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0040223
Dose Level
Description

Dose Level

Data type

integer

Measurement units
  • mmg/m*2
Alias
UMLS CUI [1]
C0178602
mmg/m*2
BSA
Description

BSA

Data type

integer

Measurement units
  • m*2
Alias
UMLS CUI [1]
C0005902
m*2
Dose Admin
Description

Dose Admin

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
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Similar models

SRT501 + Bortezomib Cycle __ Day 4 (Pre Dose) - Vital Signs; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Bortezomib 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)
Date of visit
Item
Date of visit
date
C1320303 (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
Hematology
C0474523 (UMLS CUI-1)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date and time of sample
Item
Date and time of sample
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Hematology
C0474523 (UMLS CUI-1)
Item
Parameter
integer
C0549193 (UMLS CUI [1])
Parameter
Code List
Parameter
CL Item
White blood cell (WBC) count  (1)
CL Item
Hemoglobin  (2)
CL Item
Hematocrit  (3)
CL Item
Mean corpuscular haemoglobin concentration (MCHC) (4)
CL Item
Mean corpuscular hemoglobin (MCH)  (5)
CL Item
Neutrophils  (6)
CL Item
Lymphocytes  (7)
CL Item
Monocytes (8)
CL Item
Eosinophils (9)
CL Item
Basinophils (10)
CL Item
Platelets (11)
CL Item
Mean corpuscular volume (MCV)  (12)
CL Item
Red blood cell (RBC) count  (13)
CL Item
Red blood cell distribution width (RDW) (14)
Result
Item
Result
text
C1274040 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Finding
integer
C0243095 (UMLS CUI [1])
Finding
Code List
Finding
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
Item
Not Done
integer
C1272696 (UMLS CUI [1])
Not Done
Code List
Not Done
CL Item
Not Done (1)
Item Group
Clinical Chemistry, Coagulation and Electrolytes
C0008000 (UMLS CUI-1)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date and time of sample
Item
Date and time of sample
datetime
C1302413 (UMLS CUI [1])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Clinical Chemistry, Coagulation and Electrolytes
C0008000 (UMLS CUI-1)
C0005778 (UMLS CUI-2)
C0013832 (UMLS CUI-3)
Item
Parameter
integer
C0549193 (UMLS CUI [1])
Parameter
Code List
Parameter
CL Item
Sodium  (1)
CL Item
Potassium (2)
CL Item
Chloride  (3)
CL Item
Serum creatinine  (4)
CL Item
Glucose  (5)
CL Item
Phosphate (6)
CL Item
Creatinine kinase  (7)
CL Item
ALT (8)
CL Item
AST (9)
CL Item
Total bilirubin  (10)
CL Item
Alkaline phosphatase  (11)
CL Item
Calcium (12)
CL Item
Bicarbonate (13)
CL Item
Albumin (14)
CL Item
Urea (15)
CL Item
PT/INR (16)
Results
Item
Results
text
C1254595 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Finding
integer
C0243095 (UMLS CUI [1])
Finding
Code List
Finding
CL Item
Normal (1)
CL Item
Abnormal, not clinically significant (2)
CL Item
Abnormal, clinically significant (3)
Item
Not Done
integer
C1272696 (UMLS CUI [1])
Not Done
Code List
Not Done
CL Item
Not Done (1)
Item Group
Bortezomib Administration
C1176309 (UMLS CUI-1)
C1533734 (UMLS CUI-2)
Was bortezomib administered at this visit?
Item
Was bortezomib administered at this visit?
boolean
C1176309 (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])
Lot #
Item
Lot #
integer
C1115660 (UMLS CUI [1])
Time Administered
Item
Time Administered
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose Level
Item
Dose Level
integer
C0178602 (UMLS CUI [1])
BSA
Item
BSA
integer
C0005902 (UMLS CUI [1])
Dose Admin
Item
Dose Admin
integer
C3174092 (UMLS CUI [1])
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