ID
35146
Description
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
Keywords
Versions (1)
- 2/19/19 2/19/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 19, 2019
DOI
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License
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
Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment Phase
Description
Day 1 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Description
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.
Data type
datetime
Alias
- UMLS CUI [1]
- C1986447
Description
Day 2 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Description
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.
Data type
datetime
Alias
- UMLS CUI [1]
- C1986447
Description
Day 3 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Description
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.
Data type
datetime
Alias
- UMLS CUI [1]
- C1986447
Description
RLS Symptoms Diary - Last Week of Treatment Phase
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C3538994
Description
From 7 a.m. on
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
to 6:59 a.m. on
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
What was the first time your RLS symptoms began between the times above:
Data type
time
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0700364
- UMLS CUI [1,4]
- C0205435
Description
Did you have RLS symptoms in this time frame?
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0332168
Description
If Yes, continue below
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
If Yes, continue below
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
If Yes, continue below
Data type
boolean
Alias
- UMLS CUI [1]
- C0332168
Description
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
Description
Cannot be greater than or equal to 10 hours.
Data type
float
Alias
- UMLS CUI [1]
- C0332168
Description
Cannot be greater than or equal to 3 hours.
Data type
float
Alias
- UMLS CUI [1]
- C0332168
Description
Cannot be greater than or equal to 11 hours.
Data type
float
Alias
- UMLS CUI [1]
- C0332168
Description
Location of symptoms during this time frame - Check all that apply:
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0450429
- UMLS CUI-3
- C0332168
Description
1. 7:00 a.m. to 4:59 p.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Description
2. 5:00 p.m. to 7:59 p.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Description
3. 8:00 p.m. to 6:59 a.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Description
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
Description
1. 7:00 a.m. to 4:59 p.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Description
2. 5:00 p.m. to 7:59 p.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Description
3. 8:00 p.m. to 6:59 a.m.
Data type
integer
Alias
- UMLS CUI [1]
- C0332168
Similar models
Day 1 - Day 4 Subject Diary; RLS Symptoms Diary, Last Week of Treatment Phase
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)
C1457887 (UMLS CUI-2)
C3538994 (UMLS CUI-3)
C1457887 (UMLS CUI [1,2])
C0700364 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
C1457887 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
C0449238 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
C0450429 (UMLS CUI-2)
C0332168 (UMLS CUI-3)
C0439793 (UMLS CUI-2)
C0806909 (UMLS CUI-3)
C0332168 (UMLS CUI-4)