ID

20665

Beschreibung

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

Stichworte

Versionen (5)
  1. 09.03.17 09.03.17 -
  2. 09.03.17 09.03.17 -
  3. 10.03.17 10.03.17 -
  4. 13.03.17 13.03.17 -
  5. 21.04.17 21.04.17 -
Hochgeladen am

9. März 2017

DOI

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Lizenz

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

Englisch

Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulare  
Subject Information
Beschreibung

Subject Information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
12-Lead ECG Abnormalities
Beschreibung

12-Lead ECG Abnormalities

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1704258
Pharmacokinetics - Blood
Beschreibung

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Maßeinheiten
  • YYYY-MM-DD
Alias
UMLS CUI [1]
C1302413
YYYY-MM-DD
Actual time
Beschreibung

Actual time

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1]
C0040223
Hr : Min
Sample taken
Beschreibung

Sample taken

Datentyp

text

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschreibung

Sample Number

Datentyp

text

Alias
UMLS CUI [1]
C1299222
Local laboratory result data (Haematology)
Beschreibung

Local laboratory result data (Haematology)

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0474523
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Has the subject fasted?
Beschreibung

Has the subject fasted?

Datentyp

text

Alias
UMLS CUI [1]
C0015663
Haemoglobin (Hb)
Beschreibung

Haemoglobin (Hb)

Datentyp

float

Alias
UMLS CUI [1]
C0518015
Haematocrit
Beschreibung

Haematocrit

Datentyp

float

Alias
UMLS CUI [1]
C0018935
Mean cell haemoglobin (MCH)
Beschreibung

Mean cell haemoglobin (MCH)

Datentyp

float

Alias
UMLS CUI [1]
C0369183
Red blood cell count (RBC)
Beschreibung

Red blood cell count (RBC)

Datentyp

float

Alias
UMLS CUI [1]
C0014772
White blood cell count (WBC)
Beschreibung

White blood cell count (WBC)

Datentyp

float

Alias
UMLS CUI [1]
C0023508
Platelets
Beschreibung

Platelets

Datentyp

float

Alias
UMLS CUI [1]
C0032181
Lymphocytes
Beschreibung

Lymphocytes

Datentyp

float

Alias
UMLS CUI [1]
C0200635
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Alias
UMLS CUI [1]
C0200633
Monocytes
Beschreibung

Monocytes

Datentyp

float

Alias
UMLS CUI [1]
C0200637
Basophils
Beschreibung

Basophils

Datentyp

float

Alias
UMLS CUI [1]
C0200641
Eosinophils
Beschreibung

Eosinophils

Datentyp

float

Alias
UMLS CUI [1]
C0200638
Units for differential
Beschreibung

Units for differential

Datentyp

text

Alias
UMLS CUI [1,1]
C1820731
UMLS CUI [1,2]
C1519795
Local laboratory result data - (Clinical Chemistry)
Beschreibung

Local laboratory result data - (Clinical Chemistry)

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0525044
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Has the subject fasted?
Beschreibung

Has the subject fasted?

Datentyp

text

Alias
UMLS CUI [1]
C0015663
Sodium
Beschreibung

Sodium

Datentyp

float

Alias
UMLS CUI [1]
C0337443
Potassium
Beschreibung

Potassium

Datentyp

float

Alias
UMLS CUI [1]
C0202194
Urea
Beschreibung

Urea

Datentyp

float

Alias
UMLS CUI [1]
C0523961
Creatinine
Beschreibung

Creatinine

Datentyp

float

Alias
UMLS CUI [1]
C0201976
Total protein
Beschreibung

Total protein

Datentyp

float

Alias
UMLS CUI [1]
C0555903
Albumin
Beschreibung

Albumin

Datentyp

float

Alias
UMLS CUI [1]
C0201838
Total bilirubin
Beschreibung

Total bilirubin

Datentyp

float

Alias
UMLS CUI [1]
C0201913
Aspartate aminotransferase (AST)
Beschreibung

Aspartate aminotransferase (AST)

Datentyp

float

Alias
UMLS CUI [1]
C0201899
Alanine aminotransferase (ALT)
Beschreibung

Alanine aminotransferase (ALT)

Datentyp

float

Alias
UMLS CUI [1]
C0201836
Alkaline phosphatase (AP)
Beschreibung

Alkaline phosphatase (AP)

Datentyp

float

Alias
UMLS CUI [1]
C0201850
Gamma glutamyl transferase (GGT)
Beschreibung

Gamma glutamyl transferase (GGT)

Datentyp

float

Alias
UMLS CUI [1]
C0202035
Calcium
Beschreibung

Calcium

Datentyp

float

Alias
UMLS CUI [1]
C0201925
Phosphate
Beschreibung

Phosphate

Datentyp

float

Alias
UMLS CUI [1]
C0523826
Cholesterol
Beschreibung

Cholesterol

Datentyp

float

Alias
UMLS CUI [1]
C1445957
Triglycerides
Beschreibung

Triglycerides

Datentyp

float

Alias
UMLS CUI [1]
C0202236
Glucose
Beschreibung

Glucose

Datentyp

float

Alias
UMLS CUI [1]
C0202042
Creatine phosphokinase
Beschreibung

Creatine phosphokinase

Datentyp

float

Alias
UMLS CUI [1]
C0201973
Chloride
Beschreibung

Chloride

Datentyp

text

Alias
UMLS CUI [1]
C0201952
Urinalysis
Beschreibung

Urinalysis

Alias
UMLS CUI-1
C0042014
Date and time sample taken
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Laboratory name
Beschreibung

Laboratory name

Datentyp

text

Alias
UMLS CUI [1]
C1882331
Address
Beschreibung

Address

Datentyp

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0022877
Urinalysis (Dipstick) Test: pH
Beschreibung

Urinalysis (Dipstick) Test: pH

Datentyp

text

Alias
UMLS CUI [1]
C0042044
Urinalysis (Dipstick) Test: Protein
Beschreibung

Urinalysis (Dipstick) Test: Protein

Datentyp

text

Alias
UMLS CUI [1]
C0262923
Urinalysis (Dipstick) Test: Glucose
Beschreibung

Urinalysis (Dipstick) Test: Glucose

Datentyp

text

Alias
UMLS CUI [1]
C0004076
Urinalysis (Dipstick) Test: Bilirubin
Beschreibung

Urinalysis (Dipstick) Test: Bilirubin

Datentyp

text

Alias
UMLS CUI [1]
C0042040
Urinalysis (Dipstick) Test: Blood
Beschreibung

Urinalysis (Dipstick) Test: Blood

Datentyp

text

Alias
UMLS CUI [1]
C0202514
Urinalysis (Dipstick) Test: Specific Gravity
Beschreibung

Urinalysis (Dipstick) Test: Specific Gravity

Datentyp

text

Alias
UMLS CUI [1]
C0430383
Was sedimentary microscopy performed?
Beschreibung

Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

Datentyp

text

Alias
UMLS CUI [1]
C2700128
Urinalysis (Microscopy) Test: White blood cells
Beschreibung

Urinalysis (Microscopy) Test: White blood cells

Datentyp

text

Alias
UMLS CUI [1]
C0919738
Urinalysis (Microscopy) Test: Red blood cells
Beschreibung

Urinalysis (Microscopy) Test: Red blood cells

Datentyp

text

Alias
UMLS CUI [1]
C0221752
Urinalysis (Microscopy) Test: Hyaline casts
Beschreibung

Urinalysis (Microscopy) Test: Hyaline casts

Datentyp

text

Alias
UMLS CUI [1]
C1254537
Urinalysis (Microscopy) Test: Granular casts
Beschreibung

Urinalysis (Microscopy) Test: Granular casts

Datentyp

text

Alias
UMLS CUI [1]
C2697521
Urinalysis (Microscopy) Test: Cellular casts
Beschreibung

Urinalysis (Microscopy) Test: Cellular casts

Datentyp

text

Alias
UMLS CUI [1]
C2699157
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Ähnliche Modelle

Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Information
C2707520 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
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])
Item
Sample taken
text
C1277698 (UMLS CUI [1])
Sample taken
Code List
Sample taken
CL Item
Yes (1)
CL Item
No (2)
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
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)
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])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Has the subject fasted?
Code List
Has the subject fasted?
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])
Units for differential
Code List
Units for differential
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)
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])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Item
Has the subject fasted?
text
C0015663 (UMLS CUI [1])
Has the subject fasted?
Code List
Has the subject fasted?
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])
Item Group
Urinalysis
C0042014 (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])
Laboratory name
Item
Laboratory name
text
C1882331 (UMLS CUI [1])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
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])
Was sedimentary microscopy performed?
Code List
Was sedimentary microscopy performed?
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])
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