ID
21435
Beschrijving
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
Trefwoorden
Versies (5)
- 09-03-17 09-03-17 -
- 09-03-17 09-03-17 -
- 10-03-17 10-03-17 -
- 13-03-17 13-03-17 -
- 21-04-17 21-04-17 -
Geüploaded op
21 april 2017
DOI
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Licentie
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
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
12-Lead ECG Abnormalities: A. Rhythm
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0199556
Beschrijving
Sinus bradycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 40-50 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate 30-39 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus bradycardia (heart rate < 30 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085610
Beschrijving
Sinus pause
Datatype
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschrijving
Sinus tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschrijving
Ectopic supraventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschrijving
Ectopic supraventricular rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschrijving
Wandering atrial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschrijving
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschrijving
Supraventricular tachycardia (heart rate >100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039240
Beschrijving
Atrial flutter
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschrijving
Atrial fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Junctional rhythm (heart rate ≤100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional rhythm
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232208
Beschrijving
Junctional tachycardia (heart rate > 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschrijving
Ectopic ventricular beats
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschrijving
Ventricular couplets
Datatype
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschrijving
Bigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschrijving
Trigeminy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschrijving
Electrical alternans
Datatype
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschrijving
R on T phenomenon
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschrijving
Ventricular fibrillation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschrijving
Idioventricular rhythm (heart rate < 100 beats/min)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700363
Beschrijving
Sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschrijving
Non-sustained ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschrijving
Wide QRS Tachycardia (diagnosis unknown)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschrijving
Ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042514
Beschrijving
Monomorphic ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344431
Beschrijving
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschrijving
Polymorphic (sustained and non-sustained) ventricular tachycardia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0344432
Beschrijving
Artificial pacemaker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschrijving
Other abnormal rhythm
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1533266
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0430456
- UMLS CUI [1,3]
- C1704258
Beschrijving
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
Beschrijving
Left atrial abnormality (P mitrale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beschrijving
Right atrial abnormality (P pulmonale)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beschrijving
Right ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162770
Beschrijving
Intraatrial conduction delay
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346510
Beschrijving
Increased voltage consistent with left ventricular hypertrophy
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112650
Beschrijving
Other morphology
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0332437
Beschrijving
12-Lead ECG Abnormalities: C. Conduction
Alias
- UMLS CUI-1
- C0232217
Beschrijving
First degree AV block (PR interval > 200 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschrijving
Short PR interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschrijving
Second degree AV block (Mobitz type 1)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschrijving
Second degree AV block (Mobitz type 2)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschrijving
2:1 AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschrijving
Third degree AV block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschrijving
Left axis deviation (QRS axis more negative than -30°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschrijving
Right axis deviation (QRS axis more positive than +110°)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschrijving
Incomplete right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschrijving
Incomplete left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschrijving
Right bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschrijving
Left anterior hemiblock (synonymous to left anterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschrijving
Left posterior hemiblock (synonymous to left posterior fascicular block)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschrijving
Left bundle branch block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschrijving
Bifascicular block
Datatype
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschrijving
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschrijving
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0264897
- UMLS CUI [1,2]
- C0043202
Beschrijving
Prolonged QT interval
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151878
Beschrijving
QT/QTc prolongation ≥ 500 msec
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855333
Beschrijving
AV dissociation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschrijving
Other conduction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0232217
Beschrijving
12-Lead ECG Abnormalities: D. Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beschrijving
Myocardial infarction, old
Datatype
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschrijving
Myocardial infarction, anterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340293
Beschrijving
Myocardial infarction, lateral
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340312
Beschrijving
Myocardial infarction, posterior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340319
Beschrijving
Myocardial infarction, inferior
Datatype
boolean
Alias
- UMLS CUI [1]
- C0340305
Beschrijving
Myocardial infarction, septal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0746727
Beschrijving
Myocardial infarction, Non-Q wave
Datatype
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschrijving
Other myocardial infarction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0027051
Beschrijving
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C0948857
Beschrijving
Non-specific ST-T changes
Datatype
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschrijving
J point elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschrijving
ST elevation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschrijving
ST elevation-pericarditis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348119
Beschrijving
ST depression
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschrijving
ST segment abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschrijving
U waves abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438169
Beschrijving
T wave inversion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschrijving
T wave peaked
Datatype
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschrijving
T waves flat
Datatype
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschrijving
T waves biphasic
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschrijving
Notched T-waves
Datatype
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschrijving
Low QRS voltage
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschrijving
T-wave flattening/inversion
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0520888
- UMLS CUI [1,2]
- C0429059
Beschrijving
T wave abnormality, not specified
Datatype
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschrijving
Other depolarisation/repolarisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
Beschrijving
12-Lead ECG Abnormalities: Other Abnormalities
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0430456
- UMLS CUI-3
- C1704258
Beschrijving
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beschrijving
Date sample taken
Datatype
date
Maateenheden
- Day Month Year
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Actual time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Sample taken
Datatype
text
Alias
- UMLS CUI [1]
- C1277698
Beschrijving
Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Local laboratory result data (Haematology)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Haemoglobin (Hb)
Datatype
float
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Haematocrit
Datatype
float
Alias
- UMLS CUI [1]
- C0018935
Beschrijving
Mean cell haemoglobin (MCH)
Datatype
float
Alias
- UMLS CUI [1]
- C0369183
Beschrijving
Red blood cell count (RBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0014772
Beschrijving
White blood cell count (WBC)
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
Lymphocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
Neutrophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200633
Beschrijving
Monocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Basophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Eosinophils
Datatype
float
Alias
- UMLS CUI [1]
- C0200638
Beschrijving
Units for differential
Datatype
text
Alias
- UMLS CUI [1,1]
- C1820731
- UMLS CUI [1,2]
- C1519795
Beschrijving
Local laboratory result data - (Clinical Chemistry)
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0525044
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Has the subject fasted?
Datatype
text
Alias
- UMLS CUI [1]
- C0015663
Beschrijving
Sodium
Datatype
float
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium
Datatype
float
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Urea
Datatype
float
Alias
- UMLS CUI [1]
- C0523961
Beschrijving
Creatinine
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Total protein
Datatype
float
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
Albumin
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Total bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Aspartate aminotransferase (AST)
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase (ALT)
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Alkaline phosphatase (AP)
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Gamma glutamyl transferase (GGT)
Datatype
float
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
Calcium
Datatype
float
Alias
- UMLS CUI [1]
- C0201925
Beschrijving
Phosphate
Datatype
float
Alias
- UMLS CUI [1]
- C0523826
Beschrijving
Cholesterol
Datatype
float
Alias
- UMLS CUI [1]
- C1445957
Beschrijving
Triglycerides
Datatype
float
Alias
- UMLS CUI [1]
- C0202236
Beschrijving
Glucose
Datatype
float
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Creatine phosphokinase
Datatype
float
Alias
- UMLS CUI [1]
- C0201973
Beschrijving
Chloride
Datatype
text
Alias
- UMLS CUI [1]
- C0201952
Beschrijving
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
Date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Laboratory name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Urinalysis (Dipstick) Test: pH
Datatype
integer
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Urinalysis (Dipstick) Test: Protein
Datatype
float
Alias
- UMLS CUI [1]
- C0262923
Beschrijving
Urinalysis (Dipstick) Test: Glucose
Datatype
float
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Urinalysis (Dipstick) Test: Bilirubin
Datatype
float
Alias
- UMLS CUI [1]
- C0042040
Beschrijving
Urinalysis (Dipstick) Test: Blood
Datatype
float
Alias
- UMLS CUI [1]
- C0202514
Beschrijving
Urinalysis (Dipstick) Test: Specific Gravity
Datatype
float
Alias
- UMLS CUI [1]
- C0430383
Beschrijving
Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.
Datatype
text
Alias
- UMLS CUI [1]
- C2700128
Beschrijving
Urinalysis (Microscopy) Test: White blood cells
Datatype
integer
Alias
- UMLS CUI [1]
- C0919738
Beschrijving
Urinalysis (Microscopy) Test: Red blood cells
Datatype
integer
Alias
- UMLS CUI [1]
- C0221752
Beschrijving
Urinalysis (Microscopy) Test: Hyaline casts
Datatype
integer
Alias
- UMLS CUI [1]
- C1254537
Beschrijving
Urinalysis (Microscopy) Test: Granular casts
Datatype
integer
Alias
- UMLS CUI [1]
- C2697521
Beschrijving
Urinalysis (Microscopy) Test: Cellular casts
Datatype
integer
Alias
- UMLS CUI [1]
- C2699157
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C1704258 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0005767 (UMLS CUI-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])