ID

24702

Beschreibung

Study part: RLS Symptoms on the first day of the patient RLS Symptoms Diary prior to the Week 48 Visit. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Stichworte

Versionen (1)
  1. 13.08.17 13.08.17 -
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GlaxoSmithKline

Hochgeladen am

13. August 2017

DOI

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RLS Symptoms on the first day of the patient RLS Symptoms Diary prior to the Week 48 Visit Ropinirole Restless Legs Syndrom NCT00355641

Englisch

RLS Symptoms on the first day of the patient RLS Symptoms Diary prior to the Week 48 Visit

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
Doctor’s Name:
Beschreibung

Physician 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
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
RLS Symptoms on the first day of the patient
Beschreibung

RLS Symptoms on the first day of the patient

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0035258
Date
Beschreibung

From 07:00 on the morning to 06:59 of the next morning.

Datentyp

date

Alias
UMLS CUI [1]
C0011008
1. Did you take your study medication during the period listed above?
Beschreibung

medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
If Yes, what time:
Beschreibung

time medication intake

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1512806
2. Did you experience any RLS symptoms during the period listed above?
Beschreibung

Symptoms RLS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0035258
3. What was the first time your RLS symptoms began?
Beschreibung

time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
4. What time did you fall asleep?
Beschreibung

time fall sleep

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3830397
5. What time did you wake up the following morning?
Beschreibung

time wake up

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1170730
6. Which parts of your body were affected by RLS symptoms during the period listed above?
Beschreibung

site

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
7. Did you have RLS symptoms in this time frame?- 7 a.m. to 11:59 a.m.
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
7. Did you have RLS symptoms in this time frame?- 12 p.m. to 2:59 p.m.Noon
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
7. Did you have RLS symptoms in this time frame?- 3 p.m. to 5:59 p.m.
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
7. Did you have RLS symptoms in this time frame?- 6 p.m. to 8:59 p.m.
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
7. Did you have RLS symptoms in this time frame?- 9 p.m. to 11:59 p.m.
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
7. Did you have RLS symptoms in this time frame?- 12 a.m. to 6:59 a.m. Midnight
Beschreibung

time frame

Datentyp

boolean

Alias
UMLS CUI [1]
C0332168
8. What was the maximum severity of your RLS symptoms during this time frame?
Beschreibung

symptom severity

Datentyp

text

Alias
UMLS CUI [1]
C1319166
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
Beschreibung

symptom Beginning

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
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Ähnliche Modelle

RLS Symptoms on the first day of the patient RLS Symptoms Diary prior to the Week 48 Visit

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Physician 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])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
RLS Symptoms on the first day of the patient
C1457887 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
date
Item
Date
date
C0011008 (UMLS CUI [1])
medication
Item
1. Did you take your study medication during the period listed above?
boolean
C0013227 (UMLS CUI [1])
time medication intake
Item
If Yes, what time:
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
Symptoms RLS
Item
2. Did you experience any RLS symptoms during the period listed above?
boolean
C1457887 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
time
Item
3. What was the first time your RLS symptoms began?
time
C0040223 (UMLS CUI [1])
time fall sleep
Item
4. What time did you fall asleep?
time
C0040223 (UMLS CUI [1,1])
C3830397 (UMLS CUI [1,2])
time wake up
Item
5. What time did you wake up the following morning?
time
C0040223 (UMLS CUI [1,1])
C1170730 (UMLS CUI [1,2])
Item
6. Which parts of your body were affected by RLS symptoms during the period listed above?
integer
C1515974 (UMLS CUI [1])
site
Code List
6. Which parts of your body were affected by RLS symptoms during the period listed above?
CL Item
None (1)
CL Item
Below the knees (2)
CL Item
Below the hips (3)
CL Item
Arms and legs (4)
CL Item
Most of the body (5)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 7 a.m. to 11:59 a.m.
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 12 p.m. to 2:59 p.m.Noon
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 3 p.m. to 5:59 p.m.
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 6 p.m. to 8:59 p.m.
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 9 p.m. to 11:59 p.m.
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
time frame
Item
7. Did you have RLS symptoms in this time frame?- 12 a.m. to 6:59 a.m. Midnight
boolean
C0332168 (UMLS CUI [1])
Item
8. What was the maximum severity of your RLS symptoms during this time frame?
text
C1319166 (UMLS CUI [1])
symptom severity
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
None (None)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
CL Item
Very Severe (Very Severe)
Item
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
integer
C1457887 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
symptom Beginning
Code List
9. At any times you were sitting or resting, how soon afterwards did your RLS symptoms start during this time frame?
CL Item
After a very long time or never (1)
CL Item
After about an hour (2)
CL Item
After about half an hour (3)
CL Item
Within a few minutes (4)
CL Item
Immediately or almost immediately (5)
CL Item
Did not sit or rest during this time frame (6)
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