ID

35147

Beschrijving

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 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

Trefwoorden

Versies (1)
  1. 19-02-19 19-02-19 -
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GlaxoSmithKline

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19 februari 2019

DOI

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Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Engels

RLS Symptoms Diary, Screening/ Washout Phase;

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Doctor’s Name:
Beschrijving

Doctor’s Name:

Datatype

text

Alias
UMLS CUI [1]
C2361125
Telephone Number:
Beschrijving

Telephone Number:

Datatype

integer

Alias
UMLS CUI [1]
C1515258
Study Contact:
Beschrijving

Study Contact:

Datatype

text

Alias
UMLS CUI [1]
C0337611
RLS Symptoms Diary - Screening/ Washout Phase
Beschrijving

RLS Symptoms Diary - Screening/ Washout Phase

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C1457887
UMLS CUI-3
C0220908
UMLS CUI-4
C1710661
From 7 a.m. on
Beschrijving

From 7 a.m. on

Datatype

date

Alias
UMLS CUI [1]
C0808070
to 6:59 a.m. on
Beschrijving

to 6:59 a.m. on

Datatype

date

Alias
UMLS CUI [1]
C0806020
What was the first time your RLS symptoms began between the times above:
Beschrijving

What was the first time your RLS symptoms began between the times above:

Datatype

time

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0700364
UMLS CUI [1,4]
C0205435
Did you have RLS symptoms in this time frame?
Beschrijving

Did you have RLS symptoms in this time frame?

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C1457887
UMLS CUI-3
C0332168
1. 7:00 a.m. to 4:59 p.m.
Beschrijving

If Yes, continue below

Datatype

boolean

Alias
UMLS CUI [1]
C0332168
2. 5:00 p.m. to 7:59 p.m.
Beschrijving

If Yes, continue below

Datatype

boolean

Alias
UMLS CUI [1]
C0332168
3. 8:00 p.m. to 6:59 a.m.
Beschrijving

If Yes, continue below

Datatype

boolean

Alias
UMLS CUI [1]
C0332168
Estimate of total number of hours of symptoms during time frame 1 e.g., enter 1 hour and 30 minutes as 1.30
Beschrijving

Estimate of total number of hours of symptoms during time frame 1 e.g., enter 1 hour and 30 minutes as 1.30

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0449238
UMLS CUI-3
C0332168
1. 7:00 a.m. to 4:59 p.m.
Beschrijving

Cannot be greater than or equal to 10 hours.

Datatype

float

Alias
UMLS CUI [1]
C0332168
2. 5:00 p.m. to 7:59 p.m.
Beschrijving

Cannot be greater than or equal to 3 hours.

Datatype

float

Alias
UMLS CUI [1]
C0332168
3. 8:00 p.m. to 6:59 a.m.
Beschrijving

Cannot be greater than or equal to 11 hours.

Datatype

float

Alias
UMLS CUI [1]
C0332168
Location of symptoms during this time frame - Check all that apply:
Beschrijving

Location of symptoms during this time frame - Check all that apply:

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0450429
UMLS CUI-3
C0332168
1. 7:00 a.m. to 4:59 p.m.
Beschrijving

1. 7:00 a.m. to 4:59 p.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
2. 5:00 p.m. to 7:59 p.m.
Beschrijving

2. 5:00 p.m. to 7:59 p.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
3. 8:00 p.m. to 6:59 a.m.
Beschrijving

3. 8:00 p.m. to 6:59 a.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
Maximum severity of symptoms during this time frame - Check one:
Beschrijving

Maximum severity of symptoms during this time frame - Check one:

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0439793
UMLS CUI-3
C0806909
UMLS CUI-4
C0332168
1. 7:00 a.m. to 4:59 p.m.
Beschrijving

1. 7:00 a.m. to 4:59 p.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
2. 5:00 p.m. to 7:59 p.m.
Beschrijving

2. 5:00 p.m. to 7:59 p.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
3. 8:00 p.m. to 6:59 a.m.
Beschrijving

3. 8:00 p.m. to 6:59 a.m.

Datatype

integer

Alias
UMLS CUI [1]
C0332168
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Similar models

RLS Symptoms Diary, Screening/ Washout Phase;

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Doctor’s Name:
Item
Doctor’s Name:
text
C2361125 (UMLS CUI [1])
Telephone Number:
Item
Telephone Number:
integer
C1515258 (UMLS CUI [1])
Study Contact:
Item
Study Contact:
text
C0337611 (UMLS CUI [1])
Item Group
RLS Symptoms Diary - Screening/ Washout Phase
C0035258 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
C1710661 (UMLS CUI-4)
From 7 a.m. on
Item
From 7 a.m. on
date
C0808070 (UMLS CUI [1])
to 6:59 a.m. on
Item
to 6:59 a.m. on
date
C0806020 (UMLS CUI [1])
What was the first time your RLS symptoms began between the times above:
Item
What was the first time your RLS symptoms began between the times above:
time
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0700364 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
Item Group
Did you have RLS symptoms in this time frame?
C0035258 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
1. 7:00 a.m. to 4:59 p.m.
Item
1. 7:00 a.m. to 4:59 p.m.
boolean
C0332168 (UMLS CUI [1])
2. 5:00 p.m. to 7:59 p.m.
Item
2. 5:00 p.m. to 7:59 p.m.
boolean
C0332168 (UMLS CUI [1])
3. 8:00 p.m. to 6:59 a.m.
Item
3. 8:00 p.m. to 6:59 a.m.
boolean
C0332168 (UMLS CUI [1])
Item Group
Estimate of total number of hours of symptoms during time frame 1 e.g., enter 1 hour and 30 minutes as 1.30
C1457887 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
1. 7:00 a.m. to 4:59 p.m.
Item
1. 7:00 a.m. to 4:59 p.m.
float
C0332168 (UMLS CUI [1])
2. 5:00 p.m. to 7:59 p.m.
Item
2. 5:00 p.m. to 7:59 p.m.
float
C0332168 (UMLS CUI [1])
3. 8:00 p.m. to 6:59 a.m.
Item
3. 8:00 p.m. to 6:59 a.m.
float
C0332168 (UMLS CUI [1])
Item Group
Location of symptoms during this time frame - Check all that apply:
C1457887 (UMLS CUI-1)
C0450429 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
Item
1. 7:00 a.m. to 4:59 p.m.
integer
C0332168 (UMLS CUI [1])
1. 7:00 a.m. to 4:59 p.m.
Code List
1. 7:00 a.m. to 4:59 p.m.
CL Item
Right leg (1)
CL Item
Left leg (2)
CL Item
Right arm (3)
CL Item
Lwft arm (4)
CL Item
Trunk (5)
CL Item
Face/Neck (6)
Item
2. 5:00 p.m. to 7:59 p.m.
integer
C0332168 (UMLS CUI [1])
2. 5:00 p.m. to 7:59 p.m.
Code List
2. 5:00 p.m. to 7:59 p.m.
CL Item
Right leg (1)
CL Item
Left leg (2)
CL Item
Right arm (3)
CL Item
Lwft arm (4)
CL Item
Trunk (5)
CL Item
Face/Neck (6)
Item
3. 8:00 p.m. to 6:59 a.m.
integer
C0332168 (UMLS CUI [1])
3. 8:00 p.m. to 6:59 a.m.
Code List
3. 8:00 p.m. to 6:59 a.m.
CL Item
Right leg (1)
CL Item
Left leg (2)
CL Item
Right arm (3)
CL Item
Lwft arm (4)
CL Item
Trunk (5)
CL Item
Face/Neck (6)
Item Group
Maximum severity of symptoms during this time frame - Check one:
C1457887 (UMLS CUI-1)
C0439793 (UMLS CUI-2)
C0806909 (UMLS CUI-3)
C0332168 (UMLS CUI-4)
Item
1. 7:00 a.m. to 4:59 p.m.
integer
C0332168 (UMLS CUI [1])
1. 7:00 a.m. to 4:59 p.m.
Code List
1. 7:00 a.m. to 4:59 p.m.
CL Item
Very Severe (4)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
Item
2. 5:00 p.m. to 7:59 p.m.
integer
C0332168 (UMLS CUI [1])
2. 5:00 p.m. to 7:59 p.m.
Code List
2. 5:00 p.m. to 7:59 p.m.
CL Item
Very Severe (4)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
Item
3. 8:00 p.m. to 6:59 a.m.
integer
C0332168 (UMLS CUI [1])
3. 8:00 p.m. to 6:59 a.m.
Code List
3. 8:00 p.m. to 6:59 a.m.
CL Item
Very Severe (4)
CL Item
Severe (3)
CL Item
Moderate (2)
CL Item
Mild (1)
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