ID
20661
Description
Documentation Part: Unscheduled An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline
Link
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Keywords
Versions (5)
- 3/9/17 3/9/17 -
- 3/9/17 3/9/17 -
- 3/10/17 3/10/17 -
- 3/13/17 3/13/17 -
- 4/21/17 4/21/17 -
Uploaded on
March 9, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Description
Date sample taken
Data type
date
Measurement units
- YYYY-MM-DD
Alias
- UMLS CUI [1]
- C1302413
Description
Actual time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Description
Sample taken
Data type
text
Alias
- UMLS CUI [1]
- C1277698
Description
Sample Number
Data type
text
Alias
- UMLS CUI [1]
- C1299222
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Date of Assessment
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1]
- C2985720
Description
Hair and skin
Data type
text
Alias
- UMLS CUI [1]
- C0018494
- UMLS CUI [2]
- C0558035
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Lymph nodes
Data type
text
Alias
- UMLS CUI [1]
- C0024204
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Eyes
Data type
text
Alias
- UMLS CUI [1]
- C0200149
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Ears, Nose and Throat
Data type
text
Alias
- UMLS CUI [1]
- C0278350
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Breasts
Data type
text
Alias
- UMLS CUI [1]
- C0199850
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Respiratory
Data type
text
Alias
- UMLS CUI [1]
- C0599324
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Cardiovascular
Data type
text
Alias
- UMLS CUI [1]
- C3854344
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Abdomen
Data type
text
Alias
- UMLS CUI [1]
- C0562238
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Urogenital
Data type
text
Alias
- UMLS CUI [1]
- C1828035
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Pelvic
Data type
text
Alias
- UMLS CUI [1]
- C0200045
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Rectal
Data type
text
Alias
- UMLS CUI [1]
- C0199900
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Musculoskeletal
Data type
text
Alias
- UMLS CUI [1]
- C0475091
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Neurological
Data type
text
Alias
- UMLS CUI [1]
- C0027853
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Mental Status
Data type
text
Alias
- UMLS CUI [1]
- C0278060
Description
different findings should be separated by either a (;) or a (/)
Data type
text
Alias
- UMLS CUI [1]
- C0678257
Description
Pregnancy Test (Complete for Female Subjects Only)
Alias
- UMLS CUI-1
- C0032976
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Date
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Description
Planned Relative Time
Data type
text
Alias
- UMLS CUI [1]
- C0439564
Description
Planned Absolute time
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1]
- C1552097
Description
Actual time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Subject position
Data type
text
Alias
- UMLS CUI [1]
- C1262869
Description
Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Start date of ECG
Data type
date
Measurement units
- Day Month Year
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0013798
Description
Planned Relative Time
Data type
text
Alias
- UMLS CUI [1]
- C0439564
Description
Start Time of ECG
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0013798
Description
Ventricular Rate
Data type
integer
Measurement units
- Beats/min
Alias
- UMLS CUI [1]
- C2189285
Description
PR Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1287082
Description
QTc interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
Enter Code for result from following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Local laboratory result data (Haematology)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
Has the subject fasted?
Data type
text
Alias
- UMLS CUI [1]
- C0015663
Description
Haemoglobin (Hb)
Data type
float
Alias
- UMLS CUI [1]
- C0518015
Description
Haematocrit
Data type
float
Alias
- UMLS CUI [1]
- C0018935
Description
Mean cell haemoglobin (MCH)
Data type
float
Alias
- UMLS CUI [1]
- C0369183
Description
Red blood cell count (RBC)
Data type
float
Alias
- UMLS CUI [1]
- C0014772
Description
White blood cell count (WBC)
Data type
float
Alias
- UMLS CUI [1]
- C0023508
Description
Platelets
Data type
float
Alias
- UMLS CUI [1]
- C0032181
Description
Lymphocytes
Data type
float
Alias
- UMLS CUI [1]
- C0200635
Description
Neutrophils
Data type
float
Alias
- UMLS CUI [1]
- C0200633
Description
Monocytes
Data type
float
Alias
- UMLS CUI [1]
- C0200637
Description
Basophils
Data type
float
Alias
- UMLS CUI [1]
- C0200641
Description
Eosinophils
Data type
float
Alias
- UMLS CUI [1]
- C0200638
Description
Units for differential
Data type
text
Alias
- UMLS CUI [1,1]
- C1820731
- UMLS CUI [1,2]
- C1519795
Description
Local laboratory result data - (Clinical Chemistry)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0525044
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
Has the subject fasted?
Data type
text
Alias
- UMLS CUI [1]
- C0015663
Description
Sodium
Data type
float
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium
Data type
float
Alias
- UMLS CUI [1]
- C0202194
Description
Urea
Data type
float
Alias
- UMLS CUI [1]
- C0523961
Description
Creatinine
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Total protein
Data type
float
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Data type
float
Alias
- UMLS CUI [1]
- C0201838
Description
Total bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0201913
Description
Aspartate aminotransferase (AST)
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
Alanine aminotransferase (ALT)
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Alkaline phosphatase (AP)
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
Gamma glutamyl transferase (GGT)
Data type
float
Alias
- UMLS CUI [1]
- C0202035
Description
Calcium
Data type
float
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphate
Data type
float
Alias
- UMLS CUI [1]
- C0523826
Description
Cholesterol
Data type
float
Alias
- UMLS CUI [1]
- C1445957
Description
Triglycerides
Data type
float
Alias
- UMLS CUI [1]
- C0202236
Description
Glucose
Data type
float
Alias
- UMLS CUI [1]
- C0202042
Description
Creatine phosphokinase
Data type
float
Alias
- UMLS CUI [1]
- C0201973
Description
Chloride
Data type
text
Alias
- UMLS CUI [1]
- C0201952
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
Urinalysis (Dipstick) Test: pH
Data type
text
Alias
- UMLS CUI [1]
- C0042044
Description
Urinalysis (Dipstick) Test: Protein
Data type
text
Alias
- UMLS CUI [1]
- C0262923
Description
Urinalysis (Dipstick) Test: Glucose
Data type
text
Alias
- UMLS CUI [1]
- C0004076
Description
Urinalysis (Dipstick) Test: Bilirubin
Data type
text
Alias
- UMLS CUI [1]
- C0042040
Description
Urinalysis (Dipstick) Test: Blood
Data type
text
Alias
- UMLS CUI [1]
- C0202514
Description
Urinalysis (Dipstick) Test: Specific Gravity
Data type
text
Alias
- UMLS CUI [1]
- C0430383
Description
Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.
Data type
text
Alias
- UMLS CUI [1]
- C2700128
Description
Urinalysis (Microscopy) Test: White blood cells
Data type
text
Alias
- UMLS CUI [1]
- C0919738
Description
Urinalysis (Microscopy) Test: Red blood cells
Data type
text
Alias
- UMLS CUI [1]
- C0221752
Description
Urinalysis (Microscopy) Test: Hyaline casts
Data type
text
Alias
- UMLS CUI [1]
- C1254537
Description
Urinalysis (Microscopy) Test: Granular casts
Data type
text
Alias
- UMLS CUI [1]
- C2697521
Description
Urinalysis (Microscopy) Test: Cellular casts
Data type
text
Alias
- UMLS CUI [1]
- C2699157
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Similar models
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
C0005767 (UMLS CUI-2)
C0032976 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0525044 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)