ID

26188

Description

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Keywords

Versions (1)
  1. 10/10/17 10/10/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

October 10, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

English

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 forms  
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Has the subject had any changes in medication since the last study visit?
Description

If 'Yes', please document on the Concomitant Medication Report Forms.

Data type

integer

Alias
UMLS CUI [1]
C0580105
Have the subject's smoking habits remained unchanged?
Description

tobacco use unchanged

Data type

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the previous clinic visit?
Description

If 'Yes', please document on the Adverse Event Report Forms.

Data type

integer

Alias
UMLS CUI [1]
C0877248
Patient diary
Description

Patient diary

Alias
UMLS CUI-1
C3890583
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary.
Description

Patient diary

Data type

text

Alias
UMLS CUI [1]
C3890583
12-lead electrocardiogram report
Description

12-lead electrocardiogram report

Alias
UMLS CUI-1
C0430456
Actual time of ECG reading
Description

time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
heart rate
Description

heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
bpm
P-R interval
Description

P-R interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS Interval
Description

QRS Interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0520880
sec
QTc interval
Description

QTc interval

Data type

float

Measurement units
  • sec
Alias
UMLS CUI [1]
C0855331
sec
Overall ECG results
Description

ECG results

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1274040
If abnormal - clinically significant, describe
Description

Original ECGs must be kept in the patient medical charts

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C1521902
orthostatic blood pressure / Pulse
Description

orthostatic blood pressure / Pulse

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Heart Rate semi-supine
Description

Heart rate Semi-Supine

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
Heart Rate standing
Description

Heart Rate standing

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
Systolic blood pressure semi-supine
Description

Systolic blood pressure semi-supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic blood pressure semi-supine
Description

Diastolic blood pressure semi-supine

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Systolic blood pressure standing
Description

Systolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Diastolic blood pressure standing
Description

Diastolic blood pressure standing

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Pregnancy test
Description

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Description

pregnancy test

Data type

integer

If yes, what type of pregnancy test was performed?
Description

pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0032976
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

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

Result of pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0427777
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Body system
Description

Body system

Data type

integer

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0449913
Body system abnormality
Description

Body system abnormality

Data type

integer

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C1704258
Describe abnormality
Description

Describe abnormality body system

Data type

text

Alias
UMLS CUI [1,1]
C0459424
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0678257
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to the Follow-up Visit.
Description

strenuous activity

Data type

boolean

Alias
UMLS CUI [1]
C1514989
Hematology Laboratory evaluation
Description

Hematology Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0200627
Hematology not done
Description

Hematology laboratory evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0200627
Date of Sample
Description

Date of Sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Hematology Laboratory evaluation
Description

Hematology Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0200627
Analyte
Description

Analyte

Data type

integer

Alias
UMLS CUI [1]
C0443354
Result
Description

laboratory Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Unit
Description

Unit laboratory result

Data type

text

Alias
UMLS CUI [1]
C1519795
Clinical significant
Description

Clinical significant result

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Serum Laboratory evaluation
Description

Serum Laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0229671
Serum Laboratory not done
Description

Serum Laboratory evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0229671
Date of Sample
Description

Date of Sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Serum laboratory evaluation
Description

Serum laboratory evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0229671
Analyte
Description

Analyte

Data type

integer

Alias
UMLS CUI [1]
C0443354
Result
Description

laboratory Result

Data type

text

Alias
UMLS CUI [1]
C0587081
Unit
Description

Unit laboratory result

Data type

text

Alias
UMLS CUI [1]
C1519795
Clinical significant
Description

Clinical significant result

Data type

boolean

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0750502
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of examination
Description

Date of urinalysis

Data type

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0011008
Time
Description

Time of urinalysis

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Dip stick analysis
Description

Dip stick analysis

Alias
UMLS CUI-1
C1160927
pH value
Description

pH urine

Data type

float

Alias
UMLS CUI [1]
C0042044
Protein
Description

If positive for blood or protein, please perform microscopic analysis

Data type

text

Alias
UMLS CUI [1]
C0430371
Glucose
Description

Urine glucose

Data type

text

Alias
UMLS CUI [1]
C0430376
Bilirubin
Description

Urine bilirubin

Data type

text

Alias
UMLS CUI [1]
C0430374
Blood
Description

If positive for blood or protein, please perform microscopic analysis

Data type

text

Alias
UMLS CUI [1]
C0430372
microscopic analysis
Description

If positive for blood or protein, please perform microscopic analysis

Data type

boolean

Alias
UMLS CUI [1]
C0430397
Microscopic analysis
Description

Microscopic analysis

Alias
UMLS CUI-1
C0430397
Erythrocytes
Description

erythrocytes urine

Data type

integer

Measurement units
  • cells per field
Alias
UMLS CUI [1]
C2188659
Leukocytes
Description

Leukocytes urine

Data type

integer

Measurement units
  • cells per field
Alias
UMLS CUI [1]
C1254740
Bacteria
Description

Bacteria urine

Data type

integer

Alias
UMLS CUI [1,1]
C1262012
UMLS CUI [1,2]
C0004618
epithelia
Description

epithelia urine

Data type

integer

Alias
UMLS CUI [1,1]
C3828199
UMLS CUI [1,2]
C1273342
Salts
Description

salts urine

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0036140
Cast
Description

Urine cast

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0151990
Other
Description

Microscopic urinalysis other

Data type

text

Alias
UMLS CUI [1,1]
C0430397
UMLS CUI [1,2]
C0205394
Overall urinalysis assessment
Description

Overall urinalysis assessment

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C1274040
Overall urinalysis assessment
Description

Overall urinalysis assessment

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1274040
If abnormal - clinically significant, describe
Description

Urinalysis abnormal specify

Data type

text

Alias
UMLS CUI [1,1]
C0438142
UMLS CUI [1,2]
C1521902
Study Completion Part A
Description

Study Completion Part A

Alias
UMLS CUI-1
C2826970
Did the subject complete the Part A of the study?
Description

Study completion status

Data type

integer

Alias
UMLS CUI [1]
C2348577
If NO, check the one most significant reason below
Description

Reason for non completion

Data type

integer

Alias
UMLS CUI [1]
C1709849
Specify subjects request for study discontinuation
Description

Specify subjects request for study discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0332153
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify non-compliance
Description

Specify non-compliance

Data type

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify investigator's judgement
Description

Specify investigator's judgement

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify protocol violation
Description

Specify protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Specify other reason for study discontinuation
Description

Specify other reason for study discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Study Completion Part B
Description

Study Completion Part B

Alias
UMLS CUI-1
C2826970
Did the subject complete the Part B of the study?
Description

Study completion status

Data type

integer

Alias
UMLS CUI [1]
C2348577
If NO, check the one most significant reason below
Description

Reason for non completion

Data type

integer

Alias
UMLS CUI [1]
C1709849
Specify subjects request for study discontinuation
Description

Specify subjects request for study discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0332153
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify non-compliance
Description

Specify non-compliance

Data type

text

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify investigator's judgement
Description

Specify investigator's judgement

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1521902
Specify protocol violation
Description

Specify protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Specify other reason for study discontinuation
Description

Specify other reason for study discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Investigator signature
Description

Investigator signature

Alias
UMLS CUI-1
C2346576
To be completed by the Principal Investigator: I have assumed responsibility for completeness and accuracy of all data recorded on these Case Report Forms
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Print name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
changes in medication
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
tobacco use unchanged
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since the previous clinic visit?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the previous clinic visit?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Patient diary
C3890583 (UMLS CUI-1)
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary.
text
C3890583 (UMLS CUI [1])
Item Group
12-lead electrocardiogram report
C0430456 (UMLS CUI-1)
time of ECG
Item
Actual time of ECG reading
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
heart rate
Item
heart rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
P-R interval
Item
P-R interval
float
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
float
C0520880 (UMLS CUI [1])
QTc interval
Item
QTc interval
float
C0855331 (UMLS CUI [1])
Item
Overall ECG results
integer
C1623258 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
ECG results
Code List
Overall ECG results
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Specify ECG abnormality
Item
If abnormal - clinically significant, describe
text
C0522055 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
orthostatic blood pressure / Pulse
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
If yes, what type of pregnancy test was performed?
CL Item
Serum (1)
CL Item
Urine (2)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result
CL Item
positive (1)
CL Item
negative (2)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body system
integer
C1268086 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Body system
Code List
Body system
CL Item
General appearance and skin (1)
CL Item
Head, eyes, ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Respiratory (4)
CL Item
Abdominal and gastrointestinal (5)
CL Item
Musculoskeletal (6)
CL Item
Neurological (7)
CL Item
Genitourinary (8)
CL Item
other (9)
Item
Body system abnormality
integer
C0460002 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Body system abnormality
Code List
Body system abnormality
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done/ not applicable  (3)
Describe abnormality body system
Item
Describe abnormality
text
C0459424 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
strenuous activity
Item
Please confirm that the subject has refrained from strenuous activity (including competitive sports) for the 48 h prior to the Follow-up Visit.
boolean
C1514989 (UMLS CUI [1])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
Hematology laboratory evaluation
Item
Hematology not done
boolean
C0022885 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology Laboratory evaluation
C0022885 (UMLS CUI-1)
C0200627 (UMLS CUI-2)
Item
Analyte
integer
C0443354 (UMLS CUI [1])
Analyte
Code List
Analyte
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Item Group
Serum Laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
Serum Laboratory evaluation
Item
Serum Laboratory not done
boolean
C0022885 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Date of Sample
Item
Date of Sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Serum laboratory evaluation
C0022885 (UMLS CUI-1)
C0229671 (UMLS CUI-2)
Item
Analyte
integer
C0443354 (UMLS CUI [1])
Analyte
Code List
Analyte
CL Item
Sodium (1)
CL Item
Potassium (2)
CL Item
Urea (3)
CL Item
Creatinine (4)
CL Item
Protein, total (5)
CL Item
Albumin (6)
CL Item
Globulin (7)
CL Item
Bilirubin, total (8)
CL Item
AST (SGOT) (9)
CL Item
ALT (SGPT) (10)
CL Item
Alkaline phosphatase (11)
CL Item
Calcium (12)
CL Item
Phosphate (13)
CL Item
Glucose (non-fasting) (14)
CL Item
GGT (15)
CL Item
Cholesterol (16)
CL Item
Triglycerides (17)
CL Item
Creatine phosphokinase (18)
laboratory Result
Item
Result
text
C0587081 (UMLS CUI [1])
Unit laboratory result
Item
Unit
text
C1519795 (UMLS CUI [1])
Clinical significant result
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of urinalysis
Item
Date of examination
date
C0042014 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of urinalysis
Item
Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Dip stick analysis
C1160927 (UMLS CUI-1)
pH urine
Item
pH value
float
C0042044 (UMLS CUI [1])
Item
Protein
text
C0430371 (UMLS CUI [1])
Urine Protein
Code List
Protein
CL Item
neg  (neg)
CL Item
pos (pos)
Item
Glucose
text
C0430376 (UMLS CUI [1])
Urine glucose
Code List
Glucose
CL Item
neg (neg)
CL Item
pos (pos)
Item
Bilirubin
text
C0430374 (UMLS CUI [1])
Urine bilirubin
Code List
Bilirubin
CL Item
neg (neg)
CL Item
pos (pos)
Item
Blood
text
C0430372 (UMLS CUI [1])
Urine blood
Code List
Blood
CL Item
neg (neg)
CL Item
pos (pos)
urine microscopic analysis
Item
microscopic analysis
boolean
C0430397 (UMLS CUI [1])
Item Group
Microscopic analysis
C0430397 (UMLS CUI-1)
Item
Erythrocytes
integer
C2188659 (UMLS CUI [1])
erythrocytes urine
Code List
Erythrocytes
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
Item
Leukocytes
integer
C1254740 (UMLS CUI [1])
Leukocytes urine
Code List
Leukocytes
CL Item
0 - 3 (1)
CL Item
4 - 6 (2)
CL Item
7-10 (3)
CL Item
11-20 (4)
CL Item
>20 (5)
Item
Bacteria
integer
C1262012 (UMLS CUI [1,1])
C0004618 (UMLS CUI [1,2])
Bacteria urine
Code List
Bacteria
CL Item
none (1)
CL Item
few (2)
CL Item
moderate (3)
CL Item
abundant (4)
Item
epithelia
integer
C3828199 (UMLS CUI [1,1])
C1273342 (UMLS CUI [1,2])
epithelia urine
Code List
epithelia
CL Item
none (1)
CL Item
squamous (2)
CL Item
round (3)
CL Item
other (4)
salts urine
Item
Salts
text
C0430397 (UMLS CUI [1,1])
C0036140 (UMLS CUI [1,2])
Urine cast
Item
Cast
text
C0430397 (UMLS CUI [1,1])
C0151990 (UMLS CUI [1,2])
Microscopic urinalysis other
Item
Other
text
C0430397 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Overall urinalysis assessment
C0042014 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Item
Overall urinalysis assessment
integer
C0042014 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Overall urinalysis assessment
Code List
Overall urinalysis assessment
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Urinalysis abnormal specify
Item
If abnormal - clinically significant, describe
text
C0438142 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Study Completion Part A
C2826970 (UMLS CUI-1)
Item
Did the subject complete the Part A of the study?
integer
C2348577 (UMLS CUI [1])
Study completion status
Code List
Did the subject complete the Part A of the study?
CL Item
Yes (1)
CL Item
No (2)
Item
If NO, check the one most significant reason below
integer
C1709849 (UMLS CUI [1])
Reason for non completion
Code List
If NO, check the one most significant reason below
CL Item
Adverse event (if reason for discontinuation is adverse event, record the event on the Adverse Events page.) (1)
CL Item
Subject request (unrelated to AE) (2)
CL Item
Non-complicance (unrelated to AE) (3)
CL Item
Investigator judgement (4)
CL Item
Termination of subject dosing by sponsor (5)
CL Item
Protocol violation (6)
CL Item
Death; complete the Subject Death CRF (7)
CL Item
Other (8)
Specify subjects request for study discontinuation
Item
Specify subjects request for study discontinuation
text
C0332153 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify non-compliance
Item
Specify non-compliance
text
C0457432 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify investigator's judgement
Item
Specify investigator's judgement
text
C0008961 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for study discontinuation
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Study Completion Part B
C2826970 (UMLS CUI-1)
Item
Did the subject complete the Part B of the study?
integer
C2348577 (UMLS CUI [1])
Study completion status
Code List
Did the subject complete the Part B of the study?
CL Item
Yes (1)
CL Item
No (2)
Item
If NO, check the one most significant reason below
integer
C1709849 (UMLS CUI [1])
Reason for non completion
Code List
If NO, check the one most significant reason below
CL Item
Adverse event (if reason for discontinuation is adverse event, record the event on the Adverse Events page.) (1)
CL Item
Subject request (unrelated to AE) (2)
CL Item
Non-complicance (unrelated to AE) (3)
CL Item
Investigator judgement (4)
CL Item
Termination of subject dosing by sponsor (5)
CL Item
Protocol violation (6)
CL Item
Death; complete the Subject Death CRF (7)
CL Item
Other (8)
Specify subjects request for study discontinuation
Item
Specify subjects request for study discontinuation
text
C0332153 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify non-compliance
Item
Specify non-compliance
text
C0457432 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify investigator's judgement
Item
Specify investigator's judgement
text
C0008961 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for study discontinuation
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
To be completed by the Principal Investigator: I have assumed responsibility for completeness and accuracy of all data recorded on these Case Report Forms
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Print name
text
C2826892 (UMLS CUI [1])
Date of investigator signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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