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Informations:
Erreur:
ID
25029
Description
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease
Mots-clés
Versions (3)
- 24/08/2017 24/08/2017 -
- 04/09/2017 04/09/2017 -
- 20/09/2021 20/09/2021 -
Téléchargé le
24 août 2017
DOI
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Licence
Creative Commons BY-NC 3.0 Legacy
Modèle Commentaires :
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screening physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
screening physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Similar models
screening physical examination determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
time of ecg reading
Item
ACTUAL TIME OF ECG READING
time
C0013798 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0034754 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
heart rate
Item
HEART RATE
integer
C0018810 (UMLS CUI [1])
ECG: P-R Interval
Item
P-R INTERVAL
float
C0429087 (UMLS CUI [1])
QRS duration
Item
QRS DURATION
float
C0429025 (UMLS CUI [1])
QTc time
Item
QTc
float
C0860814 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal, Not clinically significant (2)
CL Item
Abnormal, Clinically significant (3)
ECG abnormality
Item
OVERALL ECG RESULTS
text
C1832603 (UMLS CUI [1])
Item Group
SCREENING PHYSICAL EXAMINATION: body measures
C0031809 (UMLS CUI-1)
C0203910 (UMLS CUI-2)
C0203910 (UMLS CUI-2)
body height
Item
HEIGHT
float
C0005890 (UMLS CUI [1])
CL Item
in (1)
CL Item
cm (2)
body weight
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
CL Item
lb (1)
CL Item
kg (2)
Item Group
SCREENING PHYSICAL EXAMINATION: vital signs
C0031809 (UMLS CUI-1)
heart rate supine
Item
HEART RATE (supine)
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
heart rate standing
Item
HEART RATE (standing)
integer
C2029905 (UMLS CUI [1])
blood pressure supine
Item
BLOOD PRESSURE (supine)
integer
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
blood pressure standing
Item
BLOOD PRESSURE (standing)
integer
C0580945 (UMLS CUI [1])
Item
GENERAL APPEARANCE & SKIN
integer
C1148438 (UMLS CUI [1])
C1123023 (UMLS CUI [2])
C1123023 (UMLS CUI [2])
CL Item
normal (1)
CL Item
abnormal (2)
general appearance and skin abnormalities
Item
GENERAL APPEARANCE & SKIN ABNORMALITY
text
C1148438 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Item
HEAD, EYES, EARS, NOSE & THROAT
integer
C0018670 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
C0013443 (UMLS CUI [3])
C0028429 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
C0015392 (UMLS CUI [2])
C0013443 (UMLS CUI [3])
C0028429 (UMLS CUI [4])
C0031354 (UMLS CUI [5])
CL Item
normal (1)
CL Item
abnormal (2)
head, eyes, ears, nose & throat abnormalities
Item
HEAD, EYES, EARS, NOSE & THROAT ABNORMALITY
text
C0018670 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0015392 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0013443 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0028429 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C0031354 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C1704258 (UMLS CUI [1,2])
C0015392 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0013443 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0028429 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C0031354 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
cardiovascular abnormalities
Item
CARDIOVASCULAR ABNORMALITY
text
C0243050 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
respiratory disorders
Item
RESPIRATORY ABNORMALITY
text
C0035204 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
gastrointestinal disorders
Item
ABDOMINAL& GASTROINTESTINAL ABNORMALITY
text
C0017178 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
musculoskeletal disorders
Item
MUSCULOSKELETAL ABNORMALITY
text
C0026857 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
neurological disorders
Item
NEUROLOGIC ABNORMALITY
text
C0027765 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
genitourinary disorder
Item
GENITOURINARY ABNORMALITY
text
C0080276 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
Item
OTHER ASPECTS ABNORMALITY
text
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])