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
Did the subject become pregnant during the study? (mark one box below)
text
C3828490 (UMLS CUI [1])
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)
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])
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)
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])
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])
Code List
Please tick the ONE most appropriate category for drop out
CL Item
Serious adverse event (1)
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])
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])
Code List
Was the subject in good condition at date of last contact?
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])
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])
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)
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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)
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])
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)
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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])
Code List
8. What was the maximum severity of your RLS symptoms during this time frame?
CL Item
Very Severe (Very Severe)
CL Item
Moderate (Moderate)
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])
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)