ID

35146

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

Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment 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
Day 1 Dosing Information
Beschrijving

Day 1 Dosing Information

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1533716
Date and time of dose:
Beschrijving

Enter the date and time you took your dose of investigational product the day after your Baseline Visit. Enter ND in Time column if a dose was missed. Dose: Refer to the Dosing Instructions on the Diary Instructions page for the time you should take your dose. This dose should be taken at the same time every day.

Datatype

datetime

Alias
UMLS CUI [1]
C1986447
Day 2 Dosing Information
Beschrijving

Day 2 Dosing Information

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1533716
Date and time of dose:
Beschrijving

Enter the date and time you took your dose of investigational product the day after your Baseline Visit. Enter ND in Time column if a dose was missed. Dose: Refer to the Dosing Instructions on the Diary Instructions page for the time you should take your dose. This dose should be taken at the same time every day.

Datatype

datetime

Alias
UMLS CUI [1]
C1986447
Day 3 Dosing Information
Beschrijving

Day 3 Dosing Information

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1533716
Date and time of dose:
Beschrijving

Enter the date and time you took your dose of investigational product the day after your Baseline Visit. Enter ND in Time column if a dose was missed. Dose: Refer to the Dosing Instructions on the Diary Instructions page for the time you should take your dose. This dose should be taken at the same time every day.

Datatype

datetime

Alias
UMLS CUI [1]
C1986447
RLS Symptoms Diary - Last Week of Treatment Phase
Beschrijving

RLS Symptoms Diary - Last Week of Treatment Phase

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C1457887
UMLS CUI-3
C3538994
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

Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment 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
Day 1 Dosing Information
C0678766 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date and time of dose:
Item
Date and time of dose:
datetime
C1986447 (UMLS CUI [1])
Item Group
Day 2 Dosing Information
C0678766 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date and time of dose:
Item
Date and time of dose:
datetime
C1986447 (UMLS CUI [1])
Item Group
Day 3 Dosing Information
C0678766 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date and time of dose:
Item
Date and time of dose:
datetime
C1986447 (UMLS CUI [1])
Item Group
RLS Symptoms Diary - Last Week of Treatment Phase
C0035258 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C3538994 (UMLS CUI-3)
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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