Information:
Fel:
ID
21435
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Nyckelord
Versioner (5)
- 2017-03-09 2017-03-09 -
- 2017-03-09 2017-03-09 -
- 2017-03-10 2017-03-10 -
- 2017-03-13 2017-03-13 -
- 2017-04-21 2017-04-21 -
Uppladdad den
21 april 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
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
Similar models
Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: A. Rhythm
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
C1704258 (UMLS CUI-2)
C0199556 (UMLS CUI-3)
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 40-50 beats/min)
Item
Sinus bradycardia (heart rate 40-50 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate 30-39 beats/min)
Item
Sinus bradycardia (heart rate 30-39 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus bradycardia (heart rate < 30 beats/min)
Item
Sinus bradycardia (heart rate < 30 beats/min)
boolean
C0085610 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Sinus tachycardia (heart rate >100 beats/min)
Item
Sinus tachycardia (heart rate >100 beats/min)
boolean
C0039239 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Ectopic supraventricular rhythm
Item
Ectopic supraventricular rhythm
boolean
C2348376 (UMLS CUI [1])
Wandering atrial pacemaker
Item
Wandering atrial pacemaker
boolean
C1321523 (UMLS CUI [1])
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min)
boolean
C0221158 (UMLS CUI [1])
Supraventricular tachycardia (heart rate >100 beats/min)
Item
Supraventricular tachycardia (heart rate >100 beats/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial fibrillation
Item
Atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
Junctional rhythm (heart rate ≤100 beats/min)
Item
Junctional rhythm (heart rate ≤100 beats/min)
boolean
C0232208 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm
boolean
C0232208 (UMLS CUI [1])
Junctional tachycardia (heart rate > 100 beats/min)
Item
Junctional tachycardia (heart rate > 100 beats/min)
boolean
C0039235 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular couplets
Item
Ventricular couplets
boolean
C0429001 (UMLS CUI [1])
Bigeminy
Item
Bigeminy
boolean
C0262662 (UMLS CUI [1])
Trigeminy
Item
Trigeminy
boolean
C0428999 (UMLS CUI [1])
Electrical alternans
Item
Electrical alternans
boolean
C1142551 (UMLS CUI [1])
R on T phenomenon
Item
R on T phenomenon
boolean
C0877658 (UMLS CUI [1])
Ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
Idioventricular rhythm (heart rate < 100 beats/min)
Item
Idioventricular rhythm (heart rate < 100 beats/min)
boolean
C0700363 (UMLS CUI [1])
Sustained ventricular tachycardia
Item
Sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Non-sustained ventricular tachycardia
Item
Non-sustained ventricular tachycardia
boolean
C0750194 (UMLS CUI [1])
Wide QRS Tachycardia (diagnosis unknown)
Item
Wide QRS Tachycardia (diagnosis unknown)
boolean
C0344429 (UMLS CUI [1])
Ventricular tachycardia
Item
Ventricular tachycardia
boolean
C0042514 (UMLS CUI [1])
Monomorphic ventricular tachycardia
Item
Monomorphic ventricular tachycardia
boolean
C0344431 (UMLS CUI [1])
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT)
boolean
C0040479 (UMLS CUI [1])
Polymorphic (sustained and non-sustained) ventricular tachycardia
Item
Polymorphic (sustained and non-sustained) ventricular tachycardia
boolean
C0344432 (UMLS CUI [1])
Artificial pacemaker
Item
Artificial pacemaker
boolean
C0030163 (UMLS CUI [1])
Other abnormal rhythm
Item
Other abnormal rhythm
boolean
C1533266 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0430456 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item Group
12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C2216025 (UMLS CUI-3)
C0429098 (UMLS CUI-4)
C1704258 (UMLS CUI-2)
C2216025 (UMLS CUI-3)
C0429098 (UMLS CUI-4)
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
Right ventricular hypertrophy
Item
Right ventricular hypertrophy
boolean
C0162770 (UMLS CUI [1])
Intraatrial conduction delay
Item
Intraatrial conduction delay
boolean
C2346510 (UMLS CUI [1])
Increased voltage consistent with left ventricular hypertrophy
Item
Increased voltage consistent with left ventricular hypertrophy
boolean
C1112650 (UMLS CUI [1])
Other morphology
Item
Other morphology
boolean
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: C. Conduction
C0232217 (UMLS CUI-1)
First degree AV block (PR interval > 200 msec)
Item
First degree AV block (PR interval > 200 msec)
boolean
C0085614 (UMLS CUI [1])
Short PR interval
Item
Short PR interval
boolean
C0520878 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
2:1 AV block
Item
2:1 AV block
boolean
C2346542 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than -30°)
Item
Left axis deviation (QRS axis more negative than -30°)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation (QRS axis more positive than +110°)
Item
Right axis deviation (QRS axis more positive than +110°)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Incomplete left bundle branch block
Item
Incomplete left bundle branch block
boolean
C0281878 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left anterior hemiblock (synonymous to left anterior fascicular block)
Item
Left anterior hemiblock (synonymous to left anterior fascicular block)
boolean
C0264912 (UMLS CUI [1])
Left posterior hemiblock (synonymous to left posterior fascicular block)
Item
Left posterior hemiblock (synonymous to left posterior fascicular block)
boolean
C0264913 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Bifascicular block
Item
Bifascicular block
boolean
C0264914 (UMLS CUI [1])
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
Item
Non-specific intraventricular conduction delay (QRS ≥ 120 msec)
boolean
C3697597 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
Prolonged QT interval
Item
Prolonged QT interval
boolean
C0151878 (UMLS CUI [1])
QT/QTc prolongation ≥ 500 msec
Item
QT/QTc prolongation ≥ 500 msec
boolean
C0855333 (UMLS CUI [1])
AV dissociation
Item
AV dissociation
boolean
C0004331 (UMLS CUI [1])
Other conduction
Item
Other conduction
boolean
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0232217 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: D. Myocardial Infarction
C0027051 (UMLS CUI-1)
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, anterior
Item
Myocardial infarction, anterior
boolean
C0340293 (UMLS CUI [1])
Myocardial infarction, lateral
Item
Myocardial infarction, lateral
boolean
C0340312 (UMLS CUI [1])
Myocardial infarction, posterior
Item
Myocardial infarction, posterior
boolean
C0340319 (UMLS CUI [1])
Myocardial infarction, inferior
Item
Myocardial infarction, inferior
boolean
C0340305 (UMLS CUI [1])
Myocardial infarction, septal
Item
Myocardial infarction, septal
boolean
C0746727 (UMLS CUI [1])
Myocardial infarction, Non-Q wave
Item
Myocardial infarction, Non-Q wave
boolean
C0542269 (UMLS CUI [1])
Other myocardial infarction
Item
Other myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T)
C0948857 (UMLS CUI-1)
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
J point elevation
Item
J point elevation
boolean
C2346597 (UMLS CUI [1])
ST elevation
Item
ST elevation
boolean
C0520886 (UMLS CUI [1])
ST elevation-pericarditis
Item
ST elevation-pericarditis
boolean
C2348119 (UMLS CUI [1])
ST depression
Item
ST depression
boolean
C0520887 (UMLS CUI [1])
ST segment abnormality, not specified
Item
ST segment abnormality, not specified
boolean
C2348120 (UMLS CUI [1])
U waves abnormal
Item
U waves abnormal
boolean
C0438169 (UMLS CUI [1])
T wave inversion
Item
T wave inversion
boolean
C0520888 (UMLS CUI [1])
T wave peaked
Item
T wave peaked
boolean
C0239242 (UMLS CUI [1])
T waves flat
Item
T waves flat
boolean
C2215959 (UMLS CUI [1])
T waves biphasic
Item
T waves biphasic
boolean
C2348639 (UMLS CUI [1])
Notched T-waves
Item
Notched T-waves
boolean
C2347367 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
T-wave flattening/inversion
Item
T-wave flattening/inversion
boolean
C0520888 (UMLS CUI [1,1])
C0429059 (UMLS CUI [1,2])
C0429059 (UMLS CUI [1,2])
T wave abnormality, not specified
Item
T wave abnormality, not specified
boolean
C0438167 (UMLS CUI [1])
Other depolarisation/repolarisation
Item
Other depolarisation/repolarisation
boolean
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item Group
12-Lead ECG Abnormalities: Other Abnormalities
C0205394 (UMLS CUI-1)
C0430456 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
C0430456 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
Other abnormalities
Item
Other abnormalities
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
801 (1)
CL Item
802 (2)
CL Item
803 (3)
CL Item
804 (4)
Item Group
Local laboratory result data (Haematology)
C1254595 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
C0474523 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
float
C0518015 (UMLS CUI [1])
Haematocrit
Item
Haematocrit
float
C0018935 (UMLS CUI [1])
Mean cell haemoglobin (MCH)
Item
Mean cell haemoglobin (MCH)
float
C0369183 (UMLS CUI [1])
Red blood cell count (RBC)
Item
Red blood cell count (RBC)
float
C0014772 (UMLS CUI [1])
White blood cell count (WBC)
Item
White blood cell count (WBC)
float
C0023508 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0032181 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0200637 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Item
Units for differential
text
C1820731 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
Percent (1)
CL Item
Absolute count (2)
Item Group
Local laboratory result data - (Clinical Chemistry)
C1254595 (UMLS CUI-1)
C0525044 (UMLS CUI-2)
C0525044 (UMLS CUI-2)
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Total protein
Item
Total protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Aspartate aminotransferase (AST)
Item
Aspartate aminotransferase (AST)
float
C0201899 (UMLS CUI [1])
Alanine aminotransferase (ALT)
Item
Alanine aminotransferase (ALT)
float
C0201836 (UMLS CUI [1])
Alkaline phosphatase (AP)
Item
Alkaline phosphatase (AP)
float
C0201850 (UMLS CUI [1])
Gamma glutamyl transferase (GGT)
Item
Gamma glutamyl transferase (GGT)
float
C0202035 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphate
Item
Phosphate
float
C0523826 (UMLS CUI [1])
Cholesterol
Item
Cholesterol
float
C1445957 (UMLS CUI [1])
Triglycerides
Item
Triglycerides
float
C0202236 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatine phosphokinase
Item
Creatine phosphokinase
float
C0201973 (UMLS CUI [1])
Chloride
Item
Chloride
text
C0201952 (UMLS CUI [1])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
Urinalysis (Dipstick) Test: pH
Item
Urinalysis (Dipstick) Test: pH
integer
C0042044 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Protein
Item
Urinalysis (Dipstick) Test: Protein
float
C0262923 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Glucose
Item
Urinalysis (Dipstick) Test: Glucose
float
C0004076 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Bilirubin
Item
Urinalysis (Dipstick) Test: Bilirubin
float
C0042040 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Blood
Item
Urinalysis (Dipstick) Test: Blood
float
C0202514 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Specific Gravity
Item
Urinalysis (Dipstick) Test: Specific Gravity
float
C0430383 (UMLS CUI [1])
Item
Was sedimentary microscopy performed?
text
C2700128 (UMLS CUI [1])
CL Item
Yes (Y)
CL Item
No (N)
Urinalysis (Microscopy) Test: White blood cells
Item
Urinalysis (Microscopy) Test: White blood cells
integer
C0919738 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Red blood cells
Item
Urinalysis (Microscopy) Test: Red blood cells
integer
C0221752 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Hyaline casts
Item
Urinalysis (Microscopy) Test: Hyaline casts
integer
C1254537 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Granular casts
Item
Urinalysis (Microscopy) Test: Granular casts
integer
C2697521 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Cellular casts
Item
Urinalysis (Microscopy) Test: Cellular casts
integer
C2699157 (UMLS CUI [1])