ID

35039

Beschreibung

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 Collaborators: N/A 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

Stichworte

Versionen (1)
  1. 12.02.19 12.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. Februar 2019

DOI

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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

Englisch

Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Medication of special Interest
Beschreibung

Medication of special Interest

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0543488
Were any of the following medications taken by the subject prior to entering this study?
Beschreibung

If Yes, record details below.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
Medication of special Interest
Beschreibung

Medication of special Interest

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0543488
Medication
Beschreibung

(Generic Name)

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
Was drug ever used?
Beschreibung

Was drug ever used?

Datentyp

boolean

Alias
UMLS CUI [1]
C0242510
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Primary Reason Medication Started
Beschreibung

Primary Reason Medication Started

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1549995
Prior RLS Treatment Medications
Beschreibung

Prior RLS Treatment Medications

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C1514463
Were any RLS treatment medications taken by the subject prior to entering this study?
Beschreibung

If Yes, record details below.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1514463
Prior RLS Treatment Medications
Beschreibung

Prior RLS Treatment Medications

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C1514463
Medication
Beschreibung

(Generic Name)

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
Was drug ever used?
Beschreibung

Was drug ever used?

Datentyp

boolean

Alias
UMLS CUI [1]
C0242510
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Did the subject respond to treatment?
Beschreibung

Did the subject respond to treatment?

Datentyp

boolean

Alias
UMLS CUI [1]
C0521982
Did the subject tolerate treatment?
Beschreibung

Did the subject tolerate treatment?

Datentyp

boolean

Alias
UMLS CUI [1]
C0013220
Other RLS medication
Beschreibung

Other RLS medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
Alcohol intake
Beschreibung

Alcohol intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschreibung

Does the subject consume alcohol?

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
If Yes, record the average number of units of alcohol consumed per week
Beschreibung

1 unit of alcohol in US = 1.5oz hard liquor, 1 beer, 4oz wine Round up to the nearest integer.

Datentyp

integer

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Caffeine Intake
Beschreibung

Caffeine Intake

Alias
UMLS CUI-1
C4062719
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
Beschreibung

Does the subject consume caffeine (coffee, tea, other caffeinated substances)?

Datentyp

boolean

Alias
UMLS CUI [1]
C4062719
If Yes, record the average number of units of caffeine consumed per day
Beschreibung

8 fluid ounces coffee = 3 units (approximately 136mg caffeine) 8 fluid ounces tea = 2 units (approximately 64mg caffeine) 8 fluid ounces caffeinated soda = 1 unit (approximately 46mg caffeine) Round up to the nearest integer.

Datentyp

integer

Maßeinheiten
  • units per day
Alias
UMLS CUI [1,1]
C4062719
UMLS CUI [1,2]
C0439505
units per day
Current Tobacco Use
Beschreibung

Current Tobacco Use

Alias
UMLS CUI-1
C0543414
UMLS CUI-2
C0521116
Does the subject currently smoke/use tobacco?
Beschreibung

Does the subject currently smoke/use tobacco?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0521116
If Yes, record average number of cigarettes smoked per day
Beschreibung

1 cigar = 7 cigarettes 1 gram (or 0.03 oz.) of tobacco = 1 cigarette Round up to the nearest integer

Datentyp

integer

Maßeinheiten
  • cigarettes per day
Alias
UMLS CUI [1]
C3694146
cigarettes per day
Restless Legs Syndrome History
Beschreibung

Restless Legs Syndrome History

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0262926
1. What was the subject’s age at the onset of RLS?
Beschreibung

1. What was the subject’s age at the onset of RLS?

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0277793
UMLS CUI [1,3]
C0035258
years
2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Beschreibung

2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0277793
UMLS CUI [1,4]
C0035258
UMLS CUI [1,5]
C0085978
If Yes, specify medication(s)
Beschreibung

If Yes, specify medication(s)

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348235
3. If female, did RLS symptoms develop during pregnancy?
Beschreibung

3. If female, did RLS symptoms develop during pregnancy?

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0032961
4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
Beschreibung

4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0026591
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0015671
UMLS CUI [3,1]
C0035258
UMLS CUI [3,2]
C0337527
UMLS CUI [4,1]
C0035258
UMLS CUI [4,2]
C0337514
UMLS CUI [5,1]
C0035258
UMLS CUI [5,2]
C0037683
UMLS CUI [6,1]
C0035258
UMLS CUI [6,2]
C0011011
5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
Beschreibung

5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0035258
If Yes, what was the subject’s age at the onset of PLMS?
Beschreibung

If Yes, what was the subject’s age at the onset of PLMS?

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0001779
years
6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
Beschreibung

6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?

Datentyp

text

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0035258
UMLS CUI [1,4]
C0026591
UMLS CUI [2,1]
C0596840
UMLS CUI [2,2]
C0037313
UMLS CUI [2,3]
C0035258
UMLS CUI [2,4]
C0015671
UMLS CUI [3,1]
C0596840
UMLS CUI [3,2]
C0037313
UMLS CUI [3,3]
C0035258
UMLS CUI [3,4]
C0337527
UMLS CUI [4,1]
C0596840
UMLS CUI [4,2]
C0037313
UMLS CUI [4,3]
C0035258
UMLS CUI [4,4]
C0337514
UMLS CUI [5,1]
C0596840
UMLS CUI [5,2]
C0037313
UMLS CUI [5,3]
C0035258
UMLS CUI [5,4]
C0037683
UMLS CUI [6,1]
C0596840
UMLS CUI [6,2]
C0037313
UMLS CUI [6,3]
C0035258
UMLS CUI [6,4]
C0011011
7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
Beschreibung

If Yes, record on the Medical Conditions page.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0851578
UMLS CUI [1,2]
C0220952
8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
Beschreibung

8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C0040223
9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
Beschreibung

9. Have any of the following parts of the subject’s body ever been affected by RLS symptoms?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0229962
International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria
Beschreibung

International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C2348561
UMLS CUI-3
C0679228
1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Beschreibung

1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.

Datentyp

boolean

Alias
UMLS CUI [1]
C1863322
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C4062607
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Beschreibung

2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1863322
UMLS CUI [1,2]
C0277814
UMLS CUI [1,3]
C0444334
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C4062607
UMLS CUI [2,4]
C0277814
UMLS CUI [2,5]
C0444334
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
Beschreibung

3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1863322
UMLS CUI [1,2]
C0026649
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C4062607
UMLS CUI [2,4]
C0564405
UMLS CUI [2,5]
C0026649
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
Beschreibung

4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1863322
UMLS CUI [1,2]
C3176727
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C4062607
UMLS CUI [2,4]
C3176727
Subject's Food Intake
Beschreibung

Subject's Food Intake

Alias
UMLS CUI-1
C0518037
Date and time of finishing last meal prior to the Screening Visit:
Beschreibung

Note: ECG measures should be taken two or more hours after a meal.

Datentyp

datetime

Alias
UMLS CUI [1]
C0578574
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Result of the ECG
Beschreibung

Check one Note: Perform ECGs in triplicate at least 2 hours after the subject’s last meal. Note: If abnormal, document abnormality in the Investigator Comment Log. Note: If any clinically significant abnormalities are noted, another ECG should be performed during the Screening and Washout Period. All clinically significant abnormalites must be resolved prior to Baseline Visit in order for the subject to be eligible for the study.

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

Screening - Medications of special Interest; RLS Treatment Medications; Alcohol and Caffeine Intake; Current Tobacco Use; Restless Legs Syndrome History; International RLS Study Group Diagnostic Criteria; Subject's Food Intake; 12-Lead ECG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Medication of special Interest
C0013227 (UMLS CUI-1)
C0543488 (UMLS CUI-2)
Were any of the following medications taken by the subject prior to entering this study?
Item
Were any of the following medications taken by the subject prior to entering this study?
boolean
C0013227 (UMLS CUI [1])
Item Group
Medication of special Interest
C0013227 (UMLS CUI-1)
C0543488 (UMLS CUI-2)
Item
Medication
integer
C0013227 (UMLS CUI [1])
Medication
Code List
Medication
CL Item
methysergide  (1)
CL Item
fenfluramine (2)
CL Item
dexfenfluramine (3)
CL Item
phentermine (4)
Was drug ever used?
Item
Was drug ever used?
boolean
C0242510 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication Stop Date
Item
Medication Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Primary Reason Medication Started
text
C0013227 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
Primary Reason Medication Started
Code List
Primary Reason Medication Started
CL Item
Migraine Headache Pain (12)
CL Item
Obesity (13)
CL Item
Other (OT)
Item Group
Prior RLS Treatment Medications
C0035258 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Were any RLS treatment medications taken by the subject prior to entering this study?
Item
Were any RLS treatment medications taken by the subject prior to entering this study?
boolean
C0035258 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Item Group
Prior RLS Treatment Medications
C0035258 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
Item
Medication
integer
C0013227 (UMLS CUI [1])
Medication
Code List
Medication
CL Item
cabergoline (1)
CL Item
pergolide  (2)
CL Item
lisuride (3)
CL Item
bromocriptine (4)
CL Item
pramipexole (5)
CL Item
levodopa (6)
CL Item
ropinirole (7)
Was drug ever used?
Item
Was drug ever used?
boolean
C0242510 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication Stop Date
Item
Medication Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Did the subject respond to treatment?
Item
Did the subject respond to treatment?
boolean
C0521982 (UMLS CUI [1])
Did the subject tolerate treatment?
Item
Did the subject tolerate treatment?
boolean
C0013220 (UMLS CUI [1])
Other RLS medication
Item
Other RLS medication
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
If Yes, record the average number of units of alcohol consumed per week
Item
If Yes, record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Caffeine Intake
C4062719 (UMLS CUI-1)
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
Item
Does the subject consume caffeine (coffee, tea, other caffeinated substances)?
boolean
C4062719 (UMLS CUI [1])
If Yes, record the average number of units of caffeine consumed per day
Item
If Yes, record the average number of units of caffeine consumed per day
integer
C4062719 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
Item Group
Current Tobacco Use
C0543414 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
Does the subject currently smoke/use tobacco?
Item
Does the subject currently smoke/use tobacco?
boolean
C0543414 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
If Yes, record average number of cigarettes smoked per day
Item
If Yes, record average number of cigarettes smoked per day
integer
C3694146 (UMLS CUI [1])
Item Group
Restless Legs Syndrome History
C0035258 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
1. What was the subject’s age at the onset of RLS?
Item
1. What was the subject’s age at the onset of RLS?
integer
C0001779 (UMLS CUI [1,1])
C0277793 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Item
2. Did the subject start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0277793 (UMLS CUI [1,3])
C0035258 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,5])
If Yes, specify medication(s)
Item
If Yes, specify medication(s)
text
C0013227 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
3. If female, did RLS symptoms develop during pregnancy?
text
C0035258 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
3. If female, did RLS symptoms develop during pregnancy?
Code List
3. If female, did RLS symptoms develop during pregnancy?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Item
4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
text
C0035258 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0035258 (UMLS CUI [2,1])
C0015671 (UMLS CUI [2,2])
C0035258 (UMLS CUI [3,1])
C0337527 (UMLS CUI [3,2])
C0035258 (UMLS CUI [4,1])
C0337514 (UMLS CUI [4,2])
C0035258 (UMLS CUI [5,1])
C0037683 (UMLS CUI [5,2])
C0035258 (UMLS CUI [6,1])
C0011011 (UMLS CUI [6,2])
4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
Code List
4. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of RLS?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
Item
5. Has the subject ever had PLMS (Periodic Limb Movements during Sleep)?
boolean
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
If Yes, what was the subject’s age at the onset of PLMS?
Item
If Yes, what was the subject’s age at the onset of PLMS?
integer
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
Item
6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
text
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
C0026591 (UMLS CUI [1,4])
C0596840 (UMLS CUI [2,1])
C0037313 (UMLS CUI [2,2])
C0035258 (UMLS CUI [2,3])
C0015671 (UMLS CUI [2,4])
C0596840 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0035258 (UMLS CUI [3,3])
C0337527 (UMLS CUI [3,4])
C0596840 (UMLS CUI [4,1])
C0037313 (UMLS CUI [4,2])
C0035258 (UMLS CUI [4,3])
C0337514 (UMLS CUI [4,4])
C0596840 (UMLS CUI [5,1])
C0037313 (UMLS CUI [5,2])
C0035258 (UMLS CUI [5,3])
C0037683 (UMLS CUI [5,4])
C0596840 (UMLS CUI [6,1])
C0037313 (UMLS CUI [6,2])
C0035258 (UMLS CUI [6,3])
C0011011 (UMLS CUI [6,4])
6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
Code List
6. Has any first degree relative (mother/father, brother/sister, son/daughter) of the subject ever been diagnosed with or had symptoms of PLMS?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
Item
7. Does the subject have any sleep disorder as defined by DSM IV other than qualifying disease state for this study?
boolean
C0851578 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
Item
8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
integer
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
Code List
8. When are the subject’s current RLS symptoms mainly present? ( ✔ only one box)
CL Item
At nighttime only (8 PM - 6:59 AM) (1)
CL Item
In evening and nighttime (5:00 PM - 6:59 AM) (2)
CL Item
Daytime, evening and nighttime (symptoms during the day, evening and night) (3)
Item
9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
integer
C0035258 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0229962 (UMLS CUI [1,3])
9. Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
Code List
9.Have any of the following parts of the subject’s body ever been affected by RLS symptoms?
CL Item
Right leg (1)
CL Item
Left leg (2)
CL Item
Right arm (3)
CL Item
Left arm (4)
CL Item
Trunk (5)
CL Item
Face or neck (6)
Item Group
International Restless Leg Syndrome Study Group (IRLSSG) Diagnostic Criteria
C0035258 (UMLS CUI-1)
C2348561 (UMLS CUI-2)
C0679228 (UMLS CUI-3)
1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
Item
1. An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs.
boolean
C1863322 (UMLS CUI [1])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
Item
2. The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
boolean
C1863322 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0444334 (UMLS CUI [1,3])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
C0277814 (UMLS CUI [2,4])
C0444334 (UMLS CUI [2,5])
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
Item
3. The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
boolean
C1863322 (UMLS CUI [1,1])
C0026649 (UMLS CUI [1,2])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
C0564405 (UMLS CUI [2,4])
C0026649 (UMLS CUI [2,5])
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
Item
4. The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night.
boolean
C1863322 (UMLS CUI [1,1])
C3176727 (UMLS CUI [1,2])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
C3176727 (UMLS CUI [2,4])
Item Group
Subject's Food Intake
C0518037 (UMLS CUI-1)
Date and time of finishing last meal prior to the Screening Visit:
Item
Date and time of finishing last meal prior to the Screening Visit:
datetime
C0578574 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
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