ID

25448

Beschreibung

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

Stichworte

Versionen (3)
  1. 24.08.17 24.08.17 -
  2. 04.09.17 04.09.17 -
  3. 20.09.21 20.09.21 -
Hochgeladen am

4. September 2017

DOI

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

Englisch

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

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschreibung

patient's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschreibung

patient number

Datentyp

integer

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

SCREENING 12-LEAD ELECTROCARDIOGRAM REPORT

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

time of ecg reading

Datentyp

time

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

heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
P-R INTERVAL
Beschreibung

ECG: P-R Interval

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0429087
sec
QRS DURATION
Beschreibung

QRS duration

Datentyp

float

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C0429025
sec
QTc
Beschreibung

QTc time

Datentyp

float

Alias
UMLS CUI [1]
C0860814
OVERALL ECG RESULTS
Beschreibung

ECG results

Datentyp

integer

Alias
UMLS CUI [1]
C1623258
OVERALL ECG RESULTS
Beschreibung

If "abnormal, clinically significant" above, describe.

Datentyp

text

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

SCREENING PHYSICAL EXAMINATION: body measures

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

body height

Datentyp

float

Alias
UMLS CUI [1]
C0005890
HEIGHT
Beschreibung

body height

Datentyp

integer

Alias
UMLS CUI [1]
C0005890
WEIGHT
Beschreibung

body weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
WEIGHT
Beschreibung

body weight

Datentyp

integer

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

SCREENING PHYSICAL EXAMINATION: vital signs

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

heart rate supine

Datentyp

integer

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

heart rate standing

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C2029905
bpm
BLOOD PRESSURE (supine)
Beschreibung

systolic & diastolic

Datentyp

integer

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

systolic & diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0580945
mmHg
BODY SYSTEMS
Beschreibung

BODY SYSTEMS

Alias
UMLS CUI-1
C0460002
GENERAL APPEARANCE & SKIN
Beschreibung

general appearance and skin

Datentyp

integer

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

If "abnormal" above, describe abnormality.

Datentyp

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
Beschreibung

head, eyes, ears, nose & throat

Datentyp

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
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

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
Beschreibung

cardiovascular system

Datentyp

integer

Alias
UMLS CUI [1]
C0007226
CARDIOVASCULAR ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0243050
RESPIRATORY
Beschreibung

respiratory system

Datentyp

integer

Alias
UMLS CUI [1]
C0035237
RESPIRATORY ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0035204
ABDOMINAL& GASTROINTESTINAL
Beschreibung

gastrointestinal tract

Datentyp

integer

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

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0017178
MUSCULOSKELETAL
Beschreibung

musculoskeletal system

Datentyp

integer

Alias
UMLS CUI [1]
C0026860
MUSCULOSKELETAL ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0026857
NEUROLOGIC
Beschreibung

neurologic system

Datentyp

integer

Alias
UMLS CUI [1]
C0027763
NEUROLOGIC ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0027765
GENITOURINARY
Beschreibung

genitourinary system

Datentyp

integer

Alias
UMLS CUI [1]
C0042066
GENITOURINARY ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1]
C0080276
OTHER
Beschreibung

Specify other aspects.

Datentyp

integer

Alias
UMLS CUI [1]
C0205394
OTHER ASPECTS ABNORMALITY
Beschreibung

If "abnormal" above, describe abnormality

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1704258
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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