ID

35147

Descrição

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

Palavras-chave

Versões (1)
  1. 19/02/2019 19/02/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

19 de fevereiro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Inglês

RLS Symptoms Diary, Screening/ Washout Phase;

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

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

Doctor’s Name:

Tipo de dados

text

Alias
UMLS CUI [1]
C2361125
Telephone Number:
Descrição

Telephone Number:

Tipo de dados

integer

Alias
UMLS CUI [1]
C1515258
Study Contact:
Descrição

Study Contact:

Tipo de dados

text

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

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
Descrição

From 7 a.m. on

Tipo de dados

date

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

to 6:59 a.m. on

Tipo de dados

date

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

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

Tipo de dados

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?
Descrição

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.
Descrição

If Yes, continue below

Tipo de dados

boolean

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

If Yes, continue below

Tipo de dados

boolean

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

If Yes, continue below

Tipo de dados

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
Descrição

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.
Descrição

Cannot be greater than or equal to 10 hours.

Tipo de dados

float

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

Cannot be greater than or equal to 3 hours.

Tipo de dados

float

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

Cannot be greater than or equal to 11 hours.

Tipo de dados

float

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

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.
Descrição

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

Tipo de dados

integer

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

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

Tipo de dados

integer

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

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

Tipo de dados

integer

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

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.
Descrição

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

Tipo de dados

integer

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

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

Tipo de dados

integer

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

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

Tipo de dados

integer

Alias
UMLS CUI [1]
C0332168
Voltar ao início da página

Similar models

RLS Symptoms Diary, Screening/ Washout Phase;

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial