ID
35146
Descripción
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
Palabras clave
Versiones (1)
- 19/2/19 19/2/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
19 de febrero de 2019
DOI
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Licencia
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
Descripción
Day 1 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Descripción
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.
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C1986447
Descripción
Day 2 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Descripción
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.
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C1986447
Descripción
Day 3 Dosing Information
Alias
- UMLS CUI-1
- C0678766
- UMLS CUI-2
- C1533716
Descripción
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.
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C1986447
Descripción
RLS Symptoms Diary - Last Week of Treatment Phase
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C3538994
Descripción
From 7 a.m. on
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0808070
Descripción
to 6:59 a.m. on
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0806020
Descripción
What was the first time your RLS symptoms began between the times above:
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0035258
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0700364
- UMLS CUI [1,4]
- C0205435
Descripción
Did you have RLS symptoms in this time frame?
Alias
- UMLS CUI-1
- C0035258
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0332168
Descripción
If Yes, continue below
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0332168
Descripción
If Yes, continue below
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0332168
Descripción
If Yes, continue below
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0332168
Descripción
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
Descripción
Cannot be greater than or equal to 10 hours.
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0332168
Descripción
Cannot be greater than or equal to 3 hours.
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0332168
Descripción
Cannot be greater than or equal to 11 hours.
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0332168
Descripción
Location of symptoms during this time frame - Check all that apply:
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0450429
- UMLS CUI-3
- C0332168
Descripción
1. 7:00 a.m. to 4:59 p.m.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332168
Descripción
2. 5:00 p.m. to 7:59 p.m.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332168
Descripción
3. 8:00 p.m. to 6:59 a.m.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332168
Descripción
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
Descripción
1. 7:00 a.m. to 4:59 p.m.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332168
Descripción
2. 5:00 p.m. to 7:59 p.m.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0332168
Descripción
3. 8:00 p.m. to 6:59 a.m.
Tipo de datos
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)