ID

25448

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2017-08-24 2017-08-24 -
  2. 2017-09-04 2017-09-04 -
  3. 2021-09-20 2021-09-20 -
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4 september 2017

DOI

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Creative Commons BY-NC 3.0 Legacy
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visit 1 screening physical examination starting dose of ropinirole Parkinson's Disease 101468/166

Engelsk

visit 1 screening physical examination starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beskrivning

patient's initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beskrivning

patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
SCREENING 12-LEAD ELECTROCARDIOGRAM REPORT
Beskrivning

SCREENING 12-LEAD ELECTROCARDIOGRAM REPORT

Alias
UMLS CUI-1
C0430456
ACTUAL TIME OF ECG READING
Beskrivning

time of ecg reading

Datatyp

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0034754
UMLS CUI [1,3]
C0040223
HEART RATE
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beskrivning

ECG: P-R Interval

Datatyp

float

Måttenheter
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beskrivning

QRS duration

Datatyp

float

Måttenheter
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beskrivning

QTc time

Datatyp

float

Alias
UMLS CUI [1]
C0860814
OVERALL ECG RESULTS
Beskrivning

ECG results

Datatyp

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beskrivning

If "abnormal, clinically significant" above, describe.

Datatyp

text

Alias
UMLS CUI [1]
C1832603
SCREENING PHYSICAL EXAMINATION: body measures
Beskrivning

SCREENING PHYSICAL EXAMINATION: body measures

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0203910
HEIGHT
Beskrivning

body height

Datatyp

float

Alias
UMLS CUI [1]
C0005890
HEIGHT
Beskrivning

body height

Datatyp

integer

Alias
UMLS CUI [1]
C0005890
WEIGHT
Beskrivning

body weight

Datatyp

float

Alias
UMLS CUI [1]
C0005910
WEIGHT
Beskrivning

body weight

Datatyp

integer

Alias
UMLS CUI [1]
C0005910
SCREENING PHYSICAL EXAMINATION: vital signs
Beskrivning

SCREENING PHYSICAL EXAMINATION: vital signs

Alias
UMLS CUI-1
C0031809
HEART RATE (supine)
Beskrivning

heart rate supine

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
bpm
HEART RATE (standing)
Beskrivning

heart rate standing

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
BLOOD PRESSURE (supine)
Beskrivning

systolic & diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
mmHg
BLOOD PRESSURE (standing)
Beskrivning

systolic & diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
BODY SYSTEMS
Beskrivning

BODY SYSTEMS

Alias
UMLS CUI-1
C0460002
GENERAL APPEARANCE & SKIN
Beskrivning

general appearance and skin

Datatyp

integer

Alias
UMLS CUI [1]
C1148438
UMLS CUI [2]
C1123023
GENERAL APPEARANCE & SKIN ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality.

Datatyp

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C1704258
HEAD, EYES, EARS, NOSE & THROAT
Beskrivning

head, eyes, ears, nose & throat

Datatyp

integer

Alias
UMLS CUI [1]
C0018670
UMLS CUI [2]
C0015392
UMLS CUI [3]
C0013443
UMLS CUI [4]
C0028429
UMLS CUI [5]
C0031354
HEAD, EYES, EARS, NOSE & THROAT ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1,1]
C0018670
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0015392
UMLS CUI [2,2]
C1704258
UMLS CUI [3,1]
C0013443
UMLS CUI [3,2]
C1704258
UMLS CUI [4,1]
C0028429
UMLS CUI [4,2]
C1704258
UMLS CUI [5,1]
C0031354
UMLS CUI [5,2]
C1704258
CARDIOVASCULAR
Beskrivning

cardiovascular system

Datatyp

integer

Alias
UMLS CUI [1]
C0007226
CARDIOVASCULAR ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0243050
RESPIRATORY
Beskrivning

respiratory system

Datatyp

integer

Alias
UMLS CUI [1]
C0035237
RESPIRATORY ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0035204
ABDOMINAL& GASTROINTESTINAL
Beskrivning

gastrointestinal tract

Datatyp

integer

Alias
UMLS CUI [1]
C0017189
ABDOMINAL& GASTROINTESTINAL ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0017178
MUSCULOSKELETAL
Beskrivning

musculoskeletal system

Datatyp

integer

Alias
UMLS CUI [1]
C0026860
MUSCULOSKELETAL ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0026857
NEUROLOGIC
Beskrivning

neurologic system

Datatyp

integer

Alias
UMLS CUI [1]
C0027763
NEUROLOGIC ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0027765
GENITOURINARY
Beskrivning

genitourinary system

Datatyp

integer

Alias
UMLS CUI [1]
C0042066
GENITOURINARY ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1]
C0080276
OTHER
Beskrivning

Specify other aspects.

Datatyp

integer

Alias
UMLS CUI [1]
C0205394
OTHER ASPECTS ABNORMALITY
Beskrivning

If "abnormal" above, describe abnormality

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1704258
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Similar models

visit 1 screening physical examination starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
Item Group
SCREENING 12-LEAD ELECTROCARDIOGRAM REPORT
C0430456 (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])
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])
Item
OVERALL ECG RESULTS
integer
C1623258 (UMLS CUI [1])
ECG results
Code List
OVERALL ECG RESULTS
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)
body height
Item
HEIGHT
float
C0005890 (UMLS CUI [1])
Item
HEIGHT
integer
C0005890 (UMLS CUI [1])
body height
Code List
HEIGHT
CL Item
in (1)
CL Item
cm (2)
body weight
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
Item
WEIGHT
integer
C0005910 (UMLS CUI [1])
body weight
Code List
WEIGHT
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])
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])
blood pressure standing
Item
BLOOD PRESSURE (standing)
integer
C0580945 (UMLS CUI [1])
Item Group
BODY SYSTEMS
C0460002 (UMLS CUI-1)
Item
GENERAL APPEARANCE & SKIN
integer
C1148438 (UMLS CUI [1])
C1123023 (UMLS CUI [2])
general appearance and skin
Code List
GENERAL APPEARANCE & SKIN
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])
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])
head, eyes, ears, nose & throat
Code List
HEAD, EYES, EARS, NOSE & THROAT
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])
Item
CARDIOVASCULAR
integer
C0007226 (UMLS CUI [1])
cardiovascular system
Code List
CARDIOVASCULAR
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
cardiovascular abnormalities
Item
CARDIOVASCULAR ABNORMALITY
text
C0243050 (UMLS CUI [1])
Item
RESPIRATORY
integer
C0035237 (UMLS CUI [1])
respiratory system
Code List
RESPIRATORY
CL Item
normal (1)
CL Item
abnormal (2)
respiratory disorders
Item
RESPIRATORY ABNORMALITY
text
C0035204 (UMLS CUI [1])
Item
ABDOMINAL& GASTROINTESTINAL
integer
C0017189 (UMLS CUI [1])
gastrointestinal tract
Code List
ABDOMINAL& GASTROINTESTINAL
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
gastrointestinal disorders
Item
ABDOMINAL& GASTROINTESTINAL ABNORMALITY
text
C0017178 (UMLS CUI [1])
Item
MUSCULOSKELETAL
integer
C0026860 (UMLS CUI [1])
musculoskeletal system
Code List
MUSCULOSKELETAL
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
musculoskeletal disorders
Item
MUSCULOSKELETAL ABNORMALITY
text
C0026857 (UMLS CUI [1])
Item
NEUROLOGIC
integer
C0027763 (UMLS CUI [1])
neurologic system
Code List
NEUROLOGIC
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
neurological disorders
Item
NEUROLOGIC ABNORMALITY
text
C0027765 (UMLS CUI [1])
Item
GENITOURINARY
integer
C0042066 (UMLS CUI [1])
genitourinary system
Code List
GENITOURINARY
CL Item
normal (1)
CL Item
abnormal (2)
CL Item
not done (3)
genitourinary disorder
Item
GENITOURINARY ABNORMALITY
text
C0080276 (UMLS CUI [1])
Item
OTHER
integer
C0205394 (UMLS CUI [1])
other aspects
Code List
OTHER
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])
other aspects
Code List
OTHER ASPECTS ABNORMALITY
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