ID

40787

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)
  1. 2020-05-13 2020-05-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 maj 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.

Tillbaka till modellkommentarer
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

Engelsk

Form D; Missing Data; Clinical Data Review

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Form D
Beskrivning

Form D

Alias
UMLS CUI-1
C0011065
Certified Cause of Death:
Beskrivning

Certified Cause of Death:

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Beskrivning

Date of Death

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Was a post-mortem carried out?
Beskrivning

If yes, please summarize findings (include diagnosis):

Datatyp

text

Alias
UMLS CUI [1]
C0004398
Post-mortem findings
Beskrivning

Post-mortem findings

Datatyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
Physician’s Signature:
Beskrivning

Physician’s Signature:

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Physician’s Signature Date:
Beskrivning

Physician’s Signature Date:

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Missing Data
Beskrivning

Missing Data

Alias
UMLS CUI-1
C0814891
Form
Beskrivning

Form

Datatyp

text

Alias
UMLS CUI [1]
C3846158
Visit
Beskrivning

Visit

Datatyp

text

Alias
UMLS CUI [1]
C0545082
Missing Data Point
Beskrivning

Missing Data Point

Datatyp

text

Alias
UMLS CUI [1]
C0814891
Missing Data - Reason
Beskrivning

Missing Data - Reason

Datatyp

text

Alias
UMLS CUI [1]
C0814891
UMLS CUI [2]
C0392360
Clinical Data Review - Administrative
Beskrivning

Clinical Data Review - Administrative

Alias
UMLS CUI-1
C1516606
UMLS CUI-2
C1320722
To Data Management
Beskrivning

To Data Management

Datatyp

text

Alias
UMLS CUI [1]
C0596404
Drug ID
Beskrivning

Drug ID

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0600091
Protocol No
Beskrivning

Protocol No

Datatyp

text

Alias
UMLS CUI [1,1]
C0442711
UMLS CUI [1,2]
C0237753
Inv.Name/Centre No
Beskrivning

Inv.Name/Centre No

Datatyp

text

Alias
UMLS CUI [1]
C2826892
UMLS CUI [2,1]
C0600091
UMLS CUI [2,2]
C0019994
Patient No
Beskrivning

Patient No

Datatyp

text

Alias
UMLS CUI [1]
C2348585
From: Medical Dept.
Beskrivning

From: Medical Dept.

Datatyp

text

Alias
UMLS CUI [1]
C1553421
CRF Module(s)
Beskrivning

CRF Module(s)

Datatyp

text

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1709061
or pages
Beskrivning

or pages

Datatyp

text

Alias
UMLS CUI [1]
C1548329
other data (questionnaires, diary, cards, etc.)
Beskrivning

other data (questionnaires, diary, cards, etc.)

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1511726
Clinical Data Review - Review comments
Beskrivning

Clinical Data Review - Review comments

Alias
UMLS CUI-1
C1516606
UMLS CUI-2
C0947611
1) Serious AE:
Beskrivning

1) Serious AE:

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
AE Text
Beskrivning

AE Text

Datatyp

text

Alias
UMLS CUI [1]
C0877248
2) Missing pages:
Beskrivning

2) Missing pages:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548329
UMLS CUI [1,2]
C1705492
To follow
Beskrivning

To follow

Datatyp

text

Alias
UMLS CUI [1]
C4281991
3) Missing data:
Beskrivning

3) Missing data:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C1511726
Page No
Beskrivning

Page No

Datatyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
To follow:
Beskrivning

To follow:

Datatyp

text

Alias
UMLS CUI [1]
C4281991
Unobtainable:
Beskrivning

Unobtainable:

Datatyp

text

Alias
UMLS CUI [1]
C2046401
4) Protocol Violations:
Beskrivning

4) Protocol Violations:

Datatyp

boolean

Alias
UMLS CUI [1]
C1709750
Page No
Beskrivning

Page No

Datatyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
5) DRQ replies:
Beskrivning

5) DRQ replies:

Datatyp

text

Alias
UMLS CUI [1]
C3846158
6) Other comments:
Beskrivning

6) Other comments:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0205394
Page No:
Beskrivning

Page No:

Datatyp

text

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
Monitor
Beskrivning

Monitor

Datatyp

text

Alias
UMLS CUI [1]
C1521743
Name:
Beskrivning

Name:

Datatyp

text

Alias
UMLS CUI [1]
C0027365
Date of review:
Beskrivning

Date of review:

Datatyp

text

Alias
UMLS CUI [1,1]
C3166277
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Form D; Missing Data; Clinical Data Review

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Form D
C0011065 (UMLS CUI-1)
Certified Cause of Death:
Item
Certified Cause of Death:
text
C0007465 (UMLS CUI [1])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was a post-mortem carried out?
Item
Was a post-mortem carried out?
text
C0004398 (UMLS CUI [1])
Post-mortem findings
Item
Post-mortem findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Physician’s Signature:
Item
Physician’s Signature:
text
C2346576 (UMLS CUI [1])
Physician’s Signature Date:
Item
Physician’s Signature Date:
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Missing Data
C0814891 (UMLS CUI-1)
Form
Item
Form
text
C3846158 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Missing Data Point
Item
Missing Data Point
text
C0814891 (UMLS CUI [1])
Missing Data - Reason
Item
Missing Data - Reason
text
C0814891 (UMLS CUI [1])
C0392360 (UMLS CUI [2])
Item Group
Clinical Data Review - Administrative
C1516606 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Item
To Data Management
text
C0596404 (UMLS CUI [1])
Review comments
Code List
To Data Management
Drug ID
Item
Drug ID
text
C0013227 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Protocol No
Item
Protocol No
text
C0442711 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Inv.Name/Centre No
Item
Inv.Name/Centre No
text
C2826892 (UMLS CUI [1])
C0600091 (UMLS CUI [2,1])
C0019994 (UMLS CUI [2,2])
Patient No
Item
Patient No
text
C2348585 (UMLS CUI [1])
From: Medical Dept.
Item
From: Medical Dept.
text
C1553421 (UMLS CUI [1])
CRF Module(s)
Item
CRF Module(s)
text
C1516308 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
or pages
Item
or pages
text
C1548329 (UMLS CUI [1])
other data (questionnaires, diary, cards, etc.)
Item
other data (questionnaires, diary, cards, etc.)
text
C0205394 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Item Group
Clinical Data Review - Review comments
C1516606 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
1) Serious AE:
Item
1) Serious AE:
boolean
C1519255 (UMLS CUI [1])
AE Text
Item
AE Text
text
C0877248 (UMLS CUI [1])
2) Missing pages:
Item
2) Missing pages:
boolean
C1548329 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
To follow
Item
To follow
text
C4281991 (UMLS CUI [1])
3) Missing data:
Item
3) Missing data:
boolean
C1705492 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
Page No
Item
Page No
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
To follow:
Item
To follow:
text
C4281991 (UMLS CUI [1])
Unobtainable:
Item
Unobtainable:
text
C2046401 (UMLS CUI [1])
4) Protocol Violations:
Item
4) Protocol Violations:
boolean
C1709750 (UMLS CUI [1])
Page No
Item
Page No
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
5) DRQ replies:
Item
5) DRQ replies:
text
C3846158 (UMLS CUI [1])
6) Other comments:
Item
6) Other comments:
boolean
C0947611 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Page No:
Item
Page No:
text
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Monitor
Item
Monitor
text
C1521743 (UMLS CUI [1])
Name:
Item
Name:
text
C0027365 (UMLS CUI [1])
Date of review:
Item
Date of review:
text
C3166277 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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