ID
21435
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
April 21, 2017
DOI
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License
Creative Commons BY-NC 3.0
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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
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0199556
Description
Sinus bradycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 40-50 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate < 30 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Supraventricular tachycardia (heart rate >100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039240
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (heart rate ≤100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia (heart rate > 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ectopic ventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Idioventricular rhythm (heart rate < 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Wide QRS Tachycardia (diagnosis unknown)
Data type
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic (sustained and non-sustained) ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344432
Description
Artificial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Other abnormal rhythm
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1533266
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0430456
- UMLS CUI [1,3]
- C1704258
Description
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C2216025
- UMLS CUI-4
- C0429098
Description
Left atrial abnormality (P mitrale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C1112650
Description
Other morphology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0332437
Description
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0232217
Description
First degree AV block (PR interval > 200 msec)
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2:1 AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation (QRS axis more negative than -30°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation (QRS axis more positive than +110°)
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock (synonymous to left anterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock (synonymous to left posterior fascicular block)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Description
Prolonged QT interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0151878
Description
QT/QTc prolongation ≥ 500 msec
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Other conduction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0232217
Description
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, Non-Q wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Description
Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0027051
Description
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST elevation-pericarditis
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
ST segment abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
U waves abnormal
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
T wave inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
Notched T-waves
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T-wave flattening/inversion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Description
T wave abnormality, not specified
Data type
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
Other depolarisation/repolarisation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Description
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0430456
- UMLS CUI-3
- C1704258
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Description
Date sample taken
Data type
date
Measurement units
- Day Month Year
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
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
integer
Alias
- UMLS CUI [1]
- C0042044
Description
Urinalysis (Dipstick) Test: Protein
Data type
float
Alias
- UMLS CUI [1]
- C0262923
Description
Urinalysis (Dipstick) Test: Glucose
Data type
float
Alias
- UMLS CUI [1]
- C0004076
Description
Urinalysis (Dipstick) Test: Bilirubin
Data type
float
Alias
- UMLS CUI [1]
- C0042040
Description
Urinalysis (Dipstick) Test: Blood
Data type
float
Alias
- UMLS CUI [1]
- C0202514
Description
Urinalysis (Dipstick) Test: Specific Gravity
Data type
float
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
integer
Alias
- UMLS CUI [1]
- C0919738
Description
Urinalysis (Microscopy) Test: Red blood cells
Data type
integer
Alias
- UMLS CUI [1]
- C0221752
Description
Urinalysis (Microscopy) Test: Hyaline casts
Data type
integer
Alias
- UMLS CUI [1]
- C1254537
Description
Urinalysis (Microscopy) Test: Granular casts
Data type
integer
Alias
- UMLS CUI [1]
- C2697521
Description
Urinalysis (Microscopy) Test: Cellular casts
Data type
integer
Alias
- UMLS CUI [1]
- C2699157
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C0200345 (UMLS CUI [1,3])
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