ID

38700

Beskrivning

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

Nyckelord

  1. 2019-03-04 2019-03-04 -
  2. 2019-10-30 2019-10-30 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 oktober 2019

DOI

För en begäran logga in.

Licens

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

Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Alias
UMLS CUI-1
C1320303
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Was a physical examination performed?
Beskrivning

Was a physical examination performed?

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

If Yes, please complete below.

Datatyp

boolean

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

Date of Physical Examination

Datatyp

date

Alias
UMLS CUI [1]
C2826643
Physical Examination
Beskrivning

Physical Examination

Alias
UMLS CUI-1
C0031809
Clinical Assessment
Beskrivning

Clinical Assessment

Datatyp

integer

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

If other Clinical Assessment, please specify

Datatyp

text

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

Check one box only

Datatyp

integer

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

If clinically significant, please record on the adverse event page

Datatyp

text

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Vital Signs
Beskrivning

Vital Signs

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

If Yes, complete below

Datatyp

boolean

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

Date of assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Position
Beskrivning

Check one box only

Datatyp

integer

Alias
UMLS CUI [1]
C1262869
Systolic BP
Beskrivning

Systolic BP

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic BP
Beskrivning

Diastolic BP

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration Rate
Beskrivning

Respiration Rate

Datatyp

integer

Måttenheter
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beskrivning

Temperature

Datatyp

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Beskrivning

Check one box only

Datatyp

integer

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

Weight

Datatyp

float

Alias
UMLS CUI [1]
C0005910
Weight Unit
Beskrivning

Check one box only

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439148
12-Lead ECG
Beskrivning

12-Lead ECG

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

Was a 12-lead ECG performed?

Datatyp

boolean

Alias
UMLS CUI [1]
C0430456
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

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

Check one box only

Datatyp

integer

Alias
UMLS CUI [1]
C1262869
ECG Results
Beskrivning

ECG Results

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

Ventriculat rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT
Beskrivning

QT

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc
Beskrivning

QTc

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
QTc Formula
Beskrivning

QTc Formula

Datatyp

integer

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

ECG Findings

Alias
UMLS CUI-1
C0438154
ECG Findings
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Hematology
Beskrivning

Hematology

Alias
UMLS CUI-1
C0474523
Was sampling performed?
Beskrivning

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

Datatyp

boolean

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

Date and time of sample

Datatyp

datetime

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

(if different from main hospital laboratory)

Datatyp

text

Alias
UMLS CUI [1]
C3258037
Hematology
Beskrivning

Hematology

Alias
UMLS CUI-1
C0474523
Parameter
Beskrivning

Parameter

Datatyp

integer

Alias
UMLS CUI [1]
C0549193
Result
Beskrivning

Result

Datatyp

text

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Finding
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0243095
Not Done
Beskrivning

Not Done

Datatyp

integer

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

Clinical Chemistry, Coagulation and Electrolytes

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

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

Datatyp

boolean

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

Date and time of sample

Datatyp

datetime

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

(if different from main hospital laboratory)

Datatyp

text

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

Clinical Chemistry, Coagulation and Electrolytes

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

Parameter

Datatyp

integer

Alias
UMLS CUI [1]
C0549193
Results
Beskrivning

Results

Datatyp

text

Alias
UMLS CUI [1]
C1254595
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Finding
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0243095
Not Done
Beskrivning

Not Done

Datatyp

integer

Alias
UMLS CUI [1]
C1272696
Urinalysis dipstick results
Beskrivning

Urinalysis dipstick results

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0430370
UMLS CUI-3
C1274040
Was sampling performed?
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Date of sample
Beskrivning

Date of sample

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Beskrivning

Time of sample

Datatyp

time

Alias
UMLS CUI [1]
C4064021
Laboratory name:
Beskrivning

(if different from main hospital laboratory)

Datatyp

text

Alias
UMLS CUI [1]
C3258037
pH
Beskrivning

pH

Datatyp

integer

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

If other pH, please specify

Datatyp

text

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

Glucose

Datatyp

integer

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

If other Glucose, please specify

Datatyp

text

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

Blood

Datatyp

integer

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

If other Blood, please specify

Datatyp

text

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

Protein

Datatyp

integer

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

If other Protein, please specify.

Datatyp

text

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

Leucocytes

Datatyp

integer

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

If other Leucocytes, please specify.

Datatyp

text

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

Urinalysis microscopy results

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

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

Datatyp

integer

Alias
UMLS CUI [1]
C0200345
Date of sample
Beskrivning

Date of sample

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Time of sample
Beskrivning

Time of sample

Datatyp

time

Alias
UMLS CUI [1]
C4064021
Laboratory name:
Beskrivning

If different from main hospital laboratory

Datatyp

text

Alias
UMLS CUI [1]
C3258037
Urinalysis microscopy results
Beskrivning

Urinalysis microscopy results

Alias
UMLS CUI-1
C0430397
UMLS CUI-2
C1274040
Parameter
Beskrivning

Parameter

Datatyp

integer

Alias
UMLS CUI [1]
C0549193
Result
Beskrivning

Result

Datatyp

text

Alias
UMLS CUI [1]
C1274040
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Not Done
Beskrivning

Not Done

Datatyp

integer

Alias
UMLS CUI [1]
C1272696
Clinically significant?
Beskrivning

Clinically significant?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826293
Serum beta-hCG Pregnancy Test
Beskrivning

Serum beta-hCG Pregnancy Test

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

If Yes, complete below

Datatyp

boolean

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

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

Datatyp

boolean

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

Date of pregnancy test

Datatyp

date

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

Check one box only

Datatyp

integer

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

PK Sampling - Plasma Samples

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C1277698
UMLS CUI-3
C1609077
Check if Not Applicable
Beskrivning

Check if Not Applicable

Datatyp

integer

Alias
UMLS CUI [1]
C1272460
Date of Sampling
Beskrivning

Date of Sampling

Datatyp

date

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

Time of Sampling

Datatyp

time

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

Check if Not Done

Datatyp

integer

Alias
UMLS CUI [1]
C1272696
Study Treatment Compliance (Return)
Beskrivning

Study Treatment Compliance (Return)

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
Beskrivning

If No, please provide the number of missed doses and the dates that the doses were missed. If No, please complete the comments page or the protocol deviations page.

Datatyp

boolean

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

No. of missed dates:

Datatyp

integer

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

Dates dose missed:

Datatyp

text

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

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?
Beskrivning

If Yes, please record details on Adverse Events page.

Datatyp

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?
Beskrivning

If Yes, please record details on Concomitant Treatment page.

Datatyp

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

Similar models

Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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])
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])
Code List
Physical Findings
CL Item
Not Done (1)
CL Item
Unchanged (2)
CL Item
If changed, normal (3)
CL Item
If changed, abnormal (4)
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])
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])
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])
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])
Code List
Position
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Item Group
ECG Results
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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)
Item
Check if Not Applicable
integer
C1272460 (UMLS CUI [1])
Code List
Check if Not Applicable
CL Item
Not Applicable (1)
Date of Sampling
Item
Date of Sampling
date
C0011008 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Time of Sampling
Item
Time of Sampling
time
C0040223 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Item
Check if Not Done
integer
C1272696 (UMLS CUI [1])
Code List
Check if Not Done
CL Item
Not Done (1)
Item Group
Study Treatment Compliance (Return)
C1321605 (UMLS CUI-1)
Has the subject been issued with a 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 received SRT501 approximately 15-30 minutes following breakfast consumption?
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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