ID

36030

Beskrivning

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the vital signs form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Nyckelord

Versioner (1)
  1. 09-04-19 09-04-19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Engelsk

Vital Signs

1 Formulär  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject No.
Beskrivning

Subject No.

Datatyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Panel ID
Beskrivning

Panel ID

Datatyp

text

Alias
UMLS CUI [1]
C3846158 (Other Coding)
LOINC
LA4728-7
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082 (Visit)
UMLS CUI [1,2]
C0332307 (Type - attribute)
SNOMED
261664005
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766 (Vital signs)
LOINC
LP30605-7
Planned relative time for predose day 1
Beskrivning

Only for predose day 1.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564 (Relative time)
SNOMED
118578006
LOINC
LP21276-8
UMLS CUI [1,2]
C0518766 (Vital signs)
LOINC
LP30605-7
Planned relative time for day 1
Beskrivning

Only for day 1.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564 (Relative time)
SNOMED
118578006
LOINC
LP21276-8
UMLS CUI [1,2]
C0518766 (Vital signs)
LOINC
LP30605-7
Planned relative time for day 2
Beskrivning

Only for day 2.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564 (Relative time)
SNOMED
118578006
LOINC
LP21276-8
UMLS CUI [1,2]
C0518766 (Vital signs)
LOINC
LP30605-7
Date of vital signs
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C2826644 (Vital Signs Date)
Time of vital signs
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C2826762 (Vital Signs Time)
Systolic Blood pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470 (Systolic Pressure)
SNOMED
271649006
mmHg
Diastolic Blood pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883 (Diastolic blood pressure)
SNOMED
271650006
mmHg
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117 (Pulse Rate)
SNOMED
78564009
bpm
Tillbaka till toppen

Similar models

Vital Signs

1 Formulär
  1. StudyEvent: ODM
    1. Vital Signs
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Item
Planned relative time for predose day 1
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for predose day 1
CL Item
Pre/Semi-supine  (1)
CL Item
Pre/Standing 1 (2)
CL Item
Pre/Semi-supine 2  (3)
CL Item
Pre/Standing 2  (4)
CL Item
Pre/Semi-supine 3  (5)
CL Item
Pre/Standing 3  (6)
CL Item
Pre/Semi-supine 4 (7)
CL Item
Pre/Standing 4  (8)
CL Item
Pre/Semi-supine 5  (9)
CL Item
Pre/Standing 5  (10)
CL Item
Pre/Semi-supine 6  (11)
CL Item
Pre/Standing 6 (12)
Item
Planned relative time for day 1
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for day 1
CL Item
+ 1 h/Semi-supine  (1)
CL Item
+ 1 h/Standing  (2)
CL Item
+ 2 h/Semi-supine  (3)
CL Item
+ 2 h/Standing  (4)
CL Item
+3 h/Semi-supine  (5)
CL Item
+3 h/Standing  (6)
CL Item
+4 h/Semi-supine  (7)
CL Item
+4 h/Standing  (8)
CL Item
+5 h/Semi-supine  (9)
CL Item
+5 h/Standing  (10)
CL Item
+6 h/Semi-supine  (11)
CL Item
+6 h/Standing (12)
Item
Planned relative time for day 2
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for day 2
CL Item
+ 16 h/Semi-supine  (1)
CL Item
+ 16 h/Standing  (2)
CL Item
+ 24 h/Semi-supine  (3)
CL Item
+ 24 h/Standing (4)
Date of vital signs
Item
Date of vital signs
date
C2826644 (UMLS CUI [1])
Time of vital signs
Item
Time of vital signs
time
C2826762 (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])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Tillbaka till toppen 

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial