ID

35575

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. 3/7/19 3/7/19 -
  2. 3/10/19 3/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 10, 2019

DOI

To request one please log in.

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, Monotherapy, Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; 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
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
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
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Was a 12-lead ECG performed?
Description

Was a 12-lead ECG performed?

Data type

boolean

Alias
UMLS CUI [1]
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Position
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C1262869
ECG Result
Description

ECG Result

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1274040
Ventriculat rate
Description

Ventriculat rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Description

QT

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Description

QTc

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
QTc Formula
Description

QTc Formula

Data type

integer

Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C1882513
ECG Findings
Description

ECG Findings

Alias
UMLS CUI-1
C0438154
ECG Findings
Description

Chcek one box only; If clinically significant please record a diagnosis on the adverse events page

Data type

integer

Alias
UMLS CUI [1]
C0438154
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
Urinalysis dipstick results
Description

Urinalysis dipstick results

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C1274040
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 of sample
Description

Date of sample

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1]
C4064021
Laboratory name:
Description

(if different from main hospital laboratory)

Data type

text

Alias
UMLS CUI [1]
C3258037
pH
Description

pH

Data type

integer

Alias
UMLS CUI [1]
C0042044
If other pH, please specify
Description

If other pH, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Glucose (mmol/L)
Description

Glucose

Data type

integer

Alias
UMLS CUI [1]
C0004076
If other Glucose, please specify
Description

If other Glucose, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Blood
Description

Blood

Data type

integer

Alias
UMLS CUI [1]
C0018965
If other Blood, please specify
Description

If other Blood, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0018965
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Protein (g/L)
Description

Protein

Data type

integer

Alias
UMLS CUI [1]
C0262923
If other Protein, please specify.
Description

If other Protein, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C0262923
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Leucocytes
Description

Leucocytes

Data type

integer

Alias
UMLS CUI [1]
C1256582
If other Leucocytes, please specify.
Description

If other Leucocytes, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C1256582
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Urinalysis microscopy results
Description

Urinalysis microscopy results

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C1274040
Was sampling performed?
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0200345
Date of sample
Description

Date of sample

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1]
C4064021
Laboratory name:
Description

If different from main hospital laboratory

Data type

text

Alias
UMLS CUI [1]
C3258037
Urinalysis microscopy results
Description

Urinalysis microscopy results

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C1274040
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
Not Done
Description

Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
Clinically significant?
Description

Clinically significant?

Data type

boolean

Alias
UMLS CUI [1]
C2826293
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
Radiographic Assessment
Description

Radiographic Assessment

Alias
UMLS CUI-1
C0444708
UMLS CUI-2
C1516048
Was radiographic scan done at this visit?
Description

If Yes, complete the following page

Data type

boolean

Alias
UMLS CUI [1,1]
C0444708
UMLS CUI [1,2]
C0441633
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Description

Time of Assessment

Data type

time

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0040223
Radiographic Assessment
Description

Radiographic Assessment

Alias
UMLS CUI-1
C0444708
UMLS CUI-2
C1516048
Lesion #
Description

Lesion #

Data type

integer

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0237753
Site of Lesion
Description

Site of Lesion

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0221198
Site Code
Description

Site Code

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0805701
If other Site, please specify
Description

If other Site, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Method of Evaluation
Description

Method of Evaluation

Data type

integer

Alias
UMLS CUI [1]
C2911685
If other Method of Evaluation, please specify.
Description

If other Method of Evaluation, please specify.

Data type

text

Alias
UMLS CUI [1,1]
C2911685
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Best Response
Description

Best Response

Data type

integer

Alias
UMLS CUI [1]
C2986560
Target Lesion
Description

Target Lesion

Data type

boolean

Alias
UMLS CUI [1]
C2986546
Measurable Lesion
Description

Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
Longest diameter at this Visit
Description

Only record diameter if the lesion is measurable

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C1522425
cm
Evaluation
Description

Evaluation

Data type

text

Alias
UMLS CUI [1]
C0220825
Disease Marker Assessment
Description

Disease Marker Assessment

Alias
UMLS CUI-1
C1511983
UMLS CUI-2
C1516048
Were Disease Markers assessed at this visit?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1,1]
C1511983
UMLS CUI [1,2]
C1516048
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Laboratory name:
Description

(if different from main hospital laboratory)

Data type

text

Alias
UMLS CUI [1]
C3258037
Disease Marker Assessment
Description

Disease Marker Assessment

Alias
UMLS CUI-1
C1511983
UMLS CUI-2
C1516048
Marker
Description

Marker

Data type

integer

Alias
UMLS CUI [1]
C0005516
If other Marker, please specify
Description

If other Marker, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0005516
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Result
Description

Result

Data type

float

Alias
UMLS CUI [1]
C1274040
Unit
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1]
C1519795
If other Unit, please specify
Description

If other Unit, please specify

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Upper Limit of Normal Range
Description

Upper Limit of Normal Range

Data type

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C2827740
Not Done
Description

Not Done

Data type

integer

Alias
UMLS CUI [1]
C1272696
Disease Response
Description

Disease Response

Alias
UMLS CUI-1
C1704632
Was Disease Response assessed at this visit?
Description

If Yes, complete below

Data type

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C1516048
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Disease response at this visit
Description

Check one box only

Data type

integer

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0545082
Date of progression
Description

Date of progression

Data type

date

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
Progression not applicable
Description

Progression not applicable

Data type

integer

Alias
UMLS CUI [1]
C0242656
Study Treatment Compliance (Return)
Description

Study Treatment Compliance (Return)

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

Check one box only 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 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]
C0013227
UMLS CUI [1,3]
C0178602
Number of missed dates
Description

Number 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

integer

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

SRT501, Monotherapy, Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; 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)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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
12-Lead ECG
C0430456 (UMLS CUI-1)
Was a 12-lead ECG performed?
Item
Was a 12-lead ECG performed?
boolean
C0430456 (UMLS CUI [1])
Date of ECG
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Position
integer
C1262869 (UMLS CUI [1])
Position
Code List
Position
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Item Group
ECG Result
C0430456 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Ventriculat rate
Item
Ventriculat rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT
Item
QT
integer
C1287082 (UMLS CUI [1])
QTc
Item
QTc
integer
C0489625 (UMLS CUI [1])
Item
QTc Formula
integer
C1882512 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
QTc Formula
Code List
QTc Formula
CL Item
Bazett (1)
CL Item
Fridericia (2)
Item Group
ECG Findings
C0438154 (UMLS CUI-1)
Item
ECG Findings
integer
C0438154 (UMLS CUI [1])
ECG Findings
Code List
ECG Findings
CL Item
Normal (1)
CL Item
Abnormal; not clinically significant  (2)
CL Item
Abnormal; clinically significant (3)
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
Urinalysis dipstick results
C0042014 (UMLS CUI-1)
C0430370 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Was sampling performed?
Item
Was sampling performed?
boolean
C0200345 (UMLS CUI [1])
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C4064021 (UMLS CUI [1])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item
pH
integer
C0042044 (UMLS CUI [1])
pH
Code List
pH
CL Item
5.0 (1)
CL Item
6.0 (2)
CL Item
6.5 (3)
CL Item
7.0 (4)
CL Item
7.5 (5)
CL Item
8.0 (6)
CL Item
8.5 (7)
CL Item
Other, please specify (8)
CL Item
Not Done (9)
If other pH, please specify
Item
If other pH, please specify
text
C0042044 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Glucose (mmol/L)
integer
C0004076 (UMLS CUI [1])
Glucose
Code List
Glucose (mmol/L)
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ 14 (2)
CL Item
++ 28 (3)
CL Item
+++ 55 (4)
CL Item
++++ >=111 (5)
CL Item
Other, please specify (6)
CL Item
Not Done (7)
If other Glucose, please specify
Item
If other Glucose, please specify
text
C0004076 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Blood
integer
C0018965 (UMLS CUI [1])
Blood
Code List
Blood
CL Item
Negative (0)
CL Item
Non-haemolysed Trace (1)
CL Item
Haemolysed Trace (2)
CL Item
+ Small (3)
CL Item
++ Moderate (4)
CL Item
+++ Large (5)
CL Item
Other Blood, please specify (6)
CL Item
Not Done (7)
If other Blood, please specify
Item
If other Blood, please specify
text
C0018965 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Protein (g/L)
integer
C0262923 (UMLS CUI [1])
Protein
Code List
Protein (g/L)
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ 0.30 (2)
CL Item
++ 1 (3)
CL Item
+++ 3 (4)
CL Item
++++ >=20 (5)
CL Item
Other, please specify (6)
CL Item
Not Done (7)
If other Protein, please specify.
Item
If other Protein, please specify.
text
C0262923 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Leucocytes
integer
C1256582 (UMLS CUI [1])
Leucocytes
Code List
Leucocytes
CL Item
Negative (0)
CL Item
Trace (1)
CL Item
+ Small (2)
CL Item
++ Moderate (3)
CL Item
+++Large (4)
CL Item
Other, please specify (5)
CL Item
Not Done (6)
If other Leucocytes, please specify.
Item
If other Leucocytes, please specify.
text
C1256582 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Urinalysis microscopy results
C0430397 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Was sampling performed?
integer
C0200345 (UMLS CUI [1])
Was sampling performed?
Code List
Was sampling performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Date of sample
Item
Date of sample
date
C1302413 (UMLS CUI [1])
Time of sample
Item
Time of sample
time
C4064021 (UMLS CUI [1])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Urinalysis microscopy results
C0430397 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Parameter
integer
C0549193 (UMLS CUI [1])
Parameter
Code List
Parameter
CL Item
RBC (1)
CL Item
WBC (2)
CL Item
Casts (3)
CL Item
Epithelial cells (4)
Result
Item
Result
text
C1274040 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Not Done
integer
C1272696 (UMLS CUI [1])
Not Done
Code List
Not Done
CL Item
Not Done (1)
Clinically significant?
Item
Clinically significant?
boolean
C2826293 (UMLS CUI [1])
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
Radiographic Assessment
C0444708 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Was radiographic scan done at this visit?
Item
Was radiographic scan done at this visit?
boolean
C0444708 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Time of Assessment
Item
Time of Assessment
time
C0220825 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Radiographic Assessment
C0444708 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Lesion #
Item
Lesion #
integer
C0221198 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Site of Lesion
Item
Site of Lesion
text
C1515974 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Site Code
integer
C1515974 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Site Code
Code List
Site Code
CL Item
Bone (01)
CL Item
Brain (02)
CL Item
Breast (03)
CL Item
Effusion/Ascites (04)
CL Item
GI (05)
CL Item
GU (06)
CL Item
Head/Neck (07)
CL Item
Liver (08)
CL Item
Lung (09)
CL Item
Nodes (10)
CL Item
Skin (11)
CL Item
Other, specify  (99)
If other Site, please specify
Item
If other Site, please specify
text
C1515974 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Method of Evaluation
integer
C2911685 (UMLS CUI [1])
Method of Evaluation
Code List
Method of Evaluation
CL Item
Clinical Examination (01)
CL Item
Chest X-ray (02)
CL Item
CT scan (non-spiral) (03)
CL Item
Spiral CT scan (04)
CL Item
MRI (05)
CL Item
Ultrasound (06)
CL Item
Bone scan (07)
CL Item
Other, specify  (99)
If other Method of Evaluation, please specify.
Item
If other Method of Evaluation, please specify.
text
C2911685 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Best Response
integer
C2986560 (UMLS CUI [1])
Best Response
Code List
Best Response
CL Item
CR (1)
CL Item
PR (2)
CL Item
MR (3)
CL Item
SD (4)
CL Item
PD (5)
CL Item
Unknown (6)
Target Lesion
Item
Target Lesion
boolean
C2986546 (UMLS CUI [1])
Measurable Lesion
Item
Measurable Lesion
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Longest diameter at this Visit
Item
Longest diameter at this Visit
float
C1301886 (UMLS CUI [1,1])
C1522425 (UMLS CUI [1,2])
Evaluation
Item
Evaluation
text
C0220825 (UMLS CUI [1])
Item Group
Disease Marker Assessment
C1511983 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Were Disease Markers assessed at this visit?
Item
Were Disease Markers assessed at this visit?
boolean
C1511983 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Laboratory name:
Item
Laboratory name:
text
C3258037 (UMLS CUI [1])
Item Group
Disease Marker Assessment
C1511983 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
Marker
integer
C0005516 (UMLS CUI [1])
Marker
Code List
Marker
CL Item
Quantitative Serum M component  (1)
CL Item
Serum immunoelectrophoresis and immunofixation  (2)
CL Item
24 Hour Urine Electrophoresis  (3)
CL Item
Bone Marrow biopsy/aspirate  (4)
CL Item
Other, specify (5)
If other Marker, please specify
Item
If other Marker, please specify
text
C0005516 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Result
Item
Result
float
C1274040 (UMLS CUI [1])
Item
Unit
integer
C1519795 (UMLS CUI [1])
Unit
Code List
Unit
CL Item
g/dL  (1)
CL Item
U/mL  (2)
CL Item
ng/mL  (3)
CL Item
Other, specify (4)
If other Unit, please specify
Item
If other Unit, please specify
text
C1519795 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Upper Limit of Normal Range
Item
Upper Limit of Normal Range
text
C0086715 (UMLS CUI [1,1])
C2827740 (UMLS CUI [1,2])
Item
Not Done
integer
C1272696 (UMLS CUI [1])
Not Done
Code List
Not Done
CL Item
Not Done (1)
Item Group
Disease Response
C1704632 (UMLS CUI-1)
Was Disease Response assessed at this visit?
Item
Was Disease Response assessed at this visit?
boolean
C1704632 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Disease response at this visit
integer
C1704632 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Disease response at this visit
Code List
Disease response at this visit
CL Item
Complete Response (CR)  (1)
CL Item
Partial Response (PR) (2)
CL Item
Minimal Response (MR)  (3)
CL Item
Stable Disease (SD)  (4)
CL Item
Progressive Disease (PD)  (5)
CL Item
Relapse from CR (6)
CL Item
Unknown (not assessable, insufficient data) (7)
Date of progression
Item
Date of progression
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Progression not applicable
integer
C0242656 (UMLS CUI [1])
Progression not applicable
Code List
Progression not applicable
CL Item
N/A (1)
Item Group
Study Treatment Compliance (Return)
C1321605 (UMLS CUI-1)
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])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Number of missed dates
Item
Number 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
integer
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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