ID

35146

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.02.19 19.02.19 -
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GlaxoSmithKline

Hochgeladen am

19. Februar 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

Englisch

Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment Phase

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

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

Doctor’s Name:

Datentyp

text

Alias
UMLS CUI [1]
C2361125
Telephone Number:
Beschreibung

Telephone Number:

Datentyp

integer

Alias
UMLS CUI [1]
C1515258
Study Contact:
Beschreibung

Study Contact:

Datentyp

text

Alias
UMLS CUI [1]
C0337611
Day 1 Dosing Information
Beschreibung

Day 1 Dosing Information

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

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.

Datentyp

datetime

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

Day 2 Dosing Information

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

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.

Datentyp

datetime

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

Day 3 Dosing Information

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

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.

Datentyp

datetime

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

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
Beschreibung

From 7 a.m. on

Datentyp

date

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

to 6:59 a.m. on

Datentyp

date

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

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

Datentyp

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?
Beschreibung

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.
Beschreibung

If Yes, continue below

Datentyp

boolean

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

If Yes, continue below

Datentyp

boolean

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

If Yes, continue below

Datentyp

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
Beschreibung

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.
Beschreibung

Cannot be greater than or equal to 10 hours.

Datentyp

float

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

Cannot be greater than or equal to 3 hours.

Datentyp

float

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

Cannot be greater than or equal to 11 hours.

Datentyp

float

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

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.
Beschreibung

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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.
Beschreibung

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

Alias
UMLS CUI [1]
C0332168
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Ähnliche Modelle

Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment Phase

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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