ID

42817

Descrizione

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

versioni (4)
  1. 22/02/18 22/02/18 -
  2. 24/02/18 24/02/18 -
  3. 25/02/18 25/02/18 -
  4. 17/09/21 17/09/21 -
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17 settembre 2021

DOI

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Ropinirole Case Report Form GSK RRL100013

Inglese

PREGNANCY INFORMATION

4 moduli  
PREGNANCY INFORMATION
Descrizione

PREGNANCY INFORMATION

MONITOR DATA VALIDATION CHECK
Descrizione

Check that responses provided correspond with the sex of the subject. If the answer to the subject pregnancy question is 'Yes', ensure that a Pregnancy Notification Form has been completed for the subject. If the answer to the female partner of the male subject pregnancy question is 'Yes', ensure that a Pregnancy Notification Form has been completed for the subject's partner.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0030695
STUDY CONCLUSION INVESTIGATOR INSTRUCTIONS
Descrizione

Refer to protocol section(s) 9 to evaluate subject completion or withdrawal from the study. If subject completed study "Date of subject completion or withdrawal" must match the last scheduled study visit date. If subject withdrew and a withdrawal visit was conducted: "Date of subject completion or withdrawal" must match the date of subject withdrawal. If subject lost to follow-up: "Date of subject completion or withdrawal" must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An 'actual contact' is defined as an interaction between the subject and the investigator or investigator's designee, where the investigatorldesignee has the opportunity to query the subject about the subject's status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1707478
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C1442085
PREGNANCY INFORMATION
Descrizione

PREGNANCY INFORMATION

Pregnancy Information
Descrizione

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study? (mark one box below)
Descrizione

If 'Yes' record details on Pregnancy Notification Form.

Tipo di dati

text

Alias
UMLS CUI [1]
C3828490
Did the female partner of a male patient become pregnant during the study? (mark one box below)
Descrizione

If 'Yes' record details on Pregnancy Notification Form.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008972
Study Conclusion
Descrizione

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
John Hopkins RLS Quality of Life questionnaire
Descrizione

John Hopkins RLS Quality of Life questionnaire

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0679830
UMLS CUI [1,4]
C0035258
MEDICAL OUTCOMES STUDY SLEEP SCALE
Descrizione

MEDICAL OUTCOMES STUDY SLEEP SCALE

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C0037313
Profile of mood states
Descrizione

Profile of mood states

Tipo di dati

text

Alias
UMLS CUI [1]
C0451394
Hospital anxiety and depression scale
Descrizione

Hospital anxiety and depression scale

Tipo di dati

text

Alias
UMLS CUI [1]
C3539657
Pittsburgh Sleep quality index
Descrizione

Pittsburgh Sleep quality index

Tipo di dati

text

Alias
UMLS CUI [1]
C0424563
Patient global improvement scale
Descrizione

Patient global improvement scale

Tipo di dati

text

Alias
UMLS CUI [1]
C0451125
PATIENT SATISFACTION QUESTION
Descrizione

PATIENT SATISFACTION QUESTION

Tipo di dati

text

Alias
UMLS CUI [1]
C3476649
Did the subject experience any Serious Adverse Event during the study period ?
Descrizione

Serious Adverse Event

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1519255
Total number of SAE's:
Descrizione

If yes, please give the total number of SAE's:

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study?
Descrizione

elimination criteria

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? If Yes, please specify
Descrizione

elimination criteria

Tipo di dati

text

Alias
UMLS CUI [1]
C0680251
Was the subject withdrawn from study?
Descrizione

withdrawn

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate category for drop out
Descrizione

If Yes, please specify

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
SAE Number
Descrizione

If Serious adverse event, please specify

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descrizione

If Non-serious adverse event, please specify

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If Protocol violation, please specify
Descrizione

Protocol violation

Tipo di dati

text

Alias
UMLS CUI [1]
C1709750
Other reason for withdrawal
Descrizione

If Other, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
reason for withdrawal, Who made the decision?
Descrizione

reason for withdrawal

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of last contact
Descrizione

Date of last contact

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Was the subject in good condition at date of last contact?
Descrizione

subject condition

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigators signature
Descrizione

Investigators signature

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Descrizione

Investigators signature Date

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
RLS Symptoms on the first day of the patient
Descrizione

RLS Symptoms on the first day of the patient

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

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

Tipo di dati

date

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

medication

Tipo di dati

boolean

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

time medication intake

Tipo di dati

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?
Descrizione

Symptoms RLS

Tipo di dati

boolean

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

time

Tipo di dati

time

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

time fall sleep

Tipo di dati

time

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

time wake up

Tipo di dati

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?
Descrizione

site

Tipo di dati

integer

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

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
RLS Symptoms on the first day of the patient
Descrizione

RLS Symptoms on the first day of the patient

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

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

Tipo di dati

date

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

medication

Tipo di dati

boolean

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

time medication intake

Tipo di dati

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?
Descrizione

Symptoms RLS

Tipo di dati

boolean

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

time

Tipo di dati

time

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

time fall sleep

Tipo di dati

time

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

time wake up

Tipo di dati

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?
Descrizione

site

Tipo di dati

integer

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

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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.
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

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
Descrizione

time frame

Tipo di dati

boolean

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

symptom severity

Tipo di dati

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?
Descrizione

symptom Beginning

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0439659
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PREGNANCY INFORMATION

4 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
PREGNANCY INFORMATION
MONITOR DATA VALIDATION CHECK
Item
MONITOR DATA VALIDATION CHECK
text
C1519941 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
STUDY CONCLUSION INVESTIGATOR INSTRUCTIONS
Item
STUDY CONCLUSION INVESTIGATOR INSTRUCTIONS
integer
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Item Group
PREGNANCY INFORMATION
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study? (mark one box below)
text
C3828490 (UMLS CUI [1])
Pregnant during study
Code List
Did the subject become pregnant during the study? (mark one box below)
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the female partner of a male patient become pregnant during the study? (mark one box below)
text
C0919624 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
undefined item
Code List
Did the female partner of a male patient become pregnant during the study? (mark one box below)
CL Item
Not applicable (subject is female, female partner not of childbearing potential or no female partner) (X)
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
John Hopkins RLS Quality of Life questionnaire
Item
John Hopkins RLS Quality of Life questionnaire
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0679830 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
MEDICAL OUTCOMES STUDY SLEEP SCALE
Item
MEDICAL OUTCOMES STUDY SLEEP SCALE
integer
C0449820 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Profile of mood states
Item
Profile of mood states
text
C0451394 (UMLS CUI [1])
Hospital anxiety and depression scale
Item
Hospital anxiety and depression scale
text
C3539657 (UMLS CUI [1])
Pittsburgh Sleep quality index
Item
Pittsburgh Sleep quality index
text
C0424563 (UMLS CUI [1])
Patient global improvement scale
Item
Patient global improvement scale
text
C0451125 (UMLS CUI [1])
Item
PATIENT SATISFACTION QUESTION
text
C3476649 (UMLS CUI [1])
PATIENT SATISFACTION QUESTION
Code List
PATIENT SATISFACTION QUESTION
CL Item
Very satisfied (Very satisfied)
C3840671 (UMLS CUI-1)
(Comment:en)
CL Item
Satisfied (Satisfied)
C4084799 (UMLS CUI-1)
(Comment:en)
CL Item
Somewhat satisfied (Somewhat satisfied)
C4053811 (UMLS CUI-1)
(Comment:en)
CL Item
Neither satisfied nor dissatisfied (Neither satisfied nor dissatisfied)
C4050008 (UMLS CUI-1)
(Comment:en)
CL Item
Somewhat dissatisfied (Somewhat dissatisfied)
C4054006 (UMLS CUI-1)
(Comment:en)
CL Item
Dissatisfied (Dissatisfied)
C4085546 (UMLS CUI-1)
(Comment:en)
CL Item
Very dissatisfied (Very dissatisfied)
C3843339 (UMLS CUI-1)
(Comment:en)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Total number of SAE's:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for drop out
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
Please tick the ONE most appropriate category for drop out
CL Item
Serious adverse event (1)
CL Item
Other (7)
CL Item
Lost to follow-up (6)
CL Item
Migrated / moved from the study area (5)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Protocol violation (3)
CL Item
Non-Serious adverse event (2)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Protocol violation
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for withdrawal, Who made the decision?
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
reason for withdrawal, Who made the decision?
CL Item
Parents/Guardian’s decision (2)
CL Item
Investigator’s decision (1)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (2)
CL Item
No, please give details within the Adverse Events section (1)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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
Most of the body (5)
CL Item
Arms and legs (4)
CL Item
Below the hips (3)
CL Item
Below the knees (2)
CL Item
None (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (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
Most of the body (5)
CL Item
Arms and legs (4)
CL Item
Below the hips (3)
CL Item
Below the knees (2)
CL Item
None (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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
Very Severe (Very Severe)
CL Item
Severe (Severe)
CL Item
Moderate (Moderate)
CL Item
Mild (Mild)
CL Item
None (None)
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
Did not sit or rest during this time frame (6)
CL Item
Immediately or almost immediately (5)
CL Item
Within a few minutes (4)
CL Item
After about half an hour (3)
CL Item
After about an hour (2)
CL Item
After a very long time or never (1)
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