ID
40432
Beskrivning
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Nyckelord
Versioner (1)
- 2020-04-20 2020-04-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 april 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Body Mass Index
Datatyp
float
Måttenheter
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
RLS Diagnostic Criteria
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C0679228
Beskrivning
1. a desire to move the limbs usually associated with paresthesias or dysesthesias
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C0596840
- UMLS CUI [1,3]
- C0030554
- UMLS CUI [1,4]
- C0392699
Beskrivning
2. motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700075
- UMLS CUI [2,1]
- C0043012
- UMLS CUI [2,2]
- C0596840
- UMLS CUI [2,3]
- C2364135
- UMLS CUI [2,4]
- C0564405
Beskrivning
3. symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C1457868
- UMLS CUI [1,3]
- C0443144
- UMLS CUI [2,1]
- C1457887
- UMLS CUI [2,2]
- C0443144
- UMLS CUI [3,1]
- C0564405
- UMLS CUI [3,2]
- C0728938
- UMLS CUI [3,3]
- C0026606
- UMLS CUI [4,1]
- C0564405
- UMLS CUI [4,2]
- C0205374
- UMLS CUI [4,3]
- C0026606
Beskrivning
4. symptoms worse in the evening or night
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3176727
Beskrivning
Significant Medical / Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Beskrivning
If yes, List below one diagnosis per line. Only in the absence of a diagnosis, record the signs and symptoms on separate lines.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [2,3]
- C0750502
Beskrivning
Significant Medical / Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C0031809
Similar models
Screening - Demography; RLS Diagnostic Criteria; Significant Medical/ Surgical History; Physical Examination
C0019994 (UMLS CUI [1,2])
C0679228 (UMLS CUI-2)
C0596840 (UMLS CUI [1,2])
C0030554 (UMLS CUI [1,3])
C0392699 (UMLS CUI [1,4])
C0043012 (UMLS CUI [2,1])
C0596840 (UMLS CUI [2,2])
C2364135 (UMLS CUI [2,3])
C0564405 (UMLS CUI [2,4])
C1457868 (UMLS CUI [1,2])
C0443144 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0564405 (UMLS CUI [3,1])
C0728938 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0564405 (UMLS CUI [4,1])
C0205374 (UMLS CUI [4,2])
C0026606 (UMLS CUI [4,3])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0750502 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0011900 (UMLS CUI [1,2])