Informazione:
Errore:
ID
42670
Descrizione
Documentation Part: Follow-Up 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
collegamento
https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1
Keywords
versioni (2)
- 09/03/17 09/03/17 -
- 17/09/21 17/09/21 -
Caricato su
17 settembre 2021
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
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Follow-Up Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Follow-Up Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Similar models
Follow-Up Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, describe concisely:
Item
If ABNORMAL, describe concisely:
text
C0678257 (UMLS CUI [1])
Item Group
Pregnancy Test (Complete for Female Subjects Only)
C0032976 (UMLS CUI-1)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Planned Absolute time
Item
Planned Absolute time
integer
C1552097 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Standing (3)
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc interval
Item
QTc interval
integer
C0489625 (UMLS CUI [1])
Result of the ECG
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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
text
C0042044 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Protein
Item
Urinalysis (Dipstick) Test: Protein
text
C0262923 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Glucose
Item
Urinalysis (Dipstick) Test: Glucose
text
C0004076 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Bilirubin
Item
Urinalysis (Dipstick) Test: Bilirubin
text
C0042040 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Blood
Item
Urinalysis (Dipstick) Test: Blood
text
C0202514 (UMLS CUI [1])
Urinalysis (Dipstick) Test: Specific Gravity
Item
Urinalysis (Dipstick) Test: Specific Gravity
text
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
text
C0919738 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Red blood cells
Item
Urinalysis (Microscopy) Test: Red blood cells
text
C0221752 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Hyaline casts
Item
Urinalysis (Microscopy) Test: Hyaline casts
text
C1254537 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Granular casts
Item
Urinalysis (Microscopy) Test: Granular casts
text
C2697521 (UMLS CUI [1])
Urinalysis (Microscopy) Test: Cellular casts
Item
Urinalysis (Microscopy) Test: Cellular casts
text
C2699157 (UMLS CUI [1])