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Informações:
Falhas:
ID
20645
Descrição
Documentation Part: Treatment Phase Day 15 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
Palavras-chave
Versões (3)
- 04/03/2017 04/03/2017 -
- 08/03/2017 08/03/2017 -
- 10/04/2017 10/04/2017 -
Transferido a
8 de março de 2017
DOI
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Licença
Creative Commons BY-NC 3.0
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Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Similar models
Treatment Phase Day 15 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0011008 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0040223 (UMLS CUI [2])
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
CL Item
positive (1)
CL Item
negative (2)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
C0868676 (UMLS CUI [1,2])
CL Item
positive (if positive, exclude subject from study) (1)
CL Item
negative (2)
Item Group
Pregnancy test (Complete for Female Subjects of Child-bearing Potential 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 (If positive, exclude subject from study) (1)
CL Item
negative (2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
CL Item
Pre-dose (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
Pre-dose (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 Invertal
Item
QTc Invertal
integer
C0860814 (UMLS CUI [1])
Result of the ECG
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
CL Item
Day 12 (7)
CL Item
Day 13 (8)
CL Item
Day 14 (9)
CL Item
Extra Dose 1 (if required) (10)
CL Item
Extra Dose 2 (if required) (11)
CL Item
Day 15 (12)
Date of dose
Item
Date of dose
date
C0013227 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Treatment confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
If No, record reason(s)
Item
If No, record reason(s)
text
C0392360 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Item Group
Ambulatory blood pressure monitoring
C0026426 (UMLS CUI-1)
C0439841 (UMLS CUI-2)
C0439841 (UMLS CUI-2)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
Stop time
Item
Stop time
time
C1522314 (UMLS CUI [1,1])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
C0026426 (UMLS CUI [1,2])
C0439841 (UMLS CUI [1,3])
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