ID

44355

Beschreibung

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Stichworte

Versionen (2)
  1. 05.03.19 05.03.19 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
RLS Screen History
Beschreibung

RLS Screen History

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0220908
UMLS CUI-3
C0262926
How old was the patient at the onset of RLS?
Beschreibung

Restless Legs Syndrome, Age of Onset

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0206132
years
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Relationships

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
If ’Yes’ please specify medication(s)
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Relationships

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
If female, did RLS symptoms develop during pregnancy?
Beschreibung

Restless Legs Syndrome, During, Pregnancy

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0032961
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
Beschreibung

Limb movement, Sleep

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
How old was the patient at the onset of PLMS?
Beschreibung

Limb movement, Sleep, Age of Onset

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0206132
years
Does the patient drink alcohol?
Beschreibung

Alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
Units/week
Beschreibung

Alcohol consumption, alcohol units/week

Datentyp

integer

Maßeinheiten
  • Units/week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Units/week
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
Beschreibung

Caffeine consumption

Datentyp

boolean

Alias
UMLS CUI [1]
C0948365
Cups/day
Beschreibung

Caffeine consumption, cups of coffee consumed per day (___cups/day)

Datentyp

integer

Maßeinheiten
  • cups/day
Alias
UMLS CUI [1,1]
C0948365
UMLS CUI [1,2]
C2164136
cups/day
Does the patient have any sleep disorder as defined by DSM IV?
Beschreibung

f ’Yes’ please record on the Significant Medical/Surgical History and Physical Examination page.

Datentyp

boolean

Alias
UMLS CUI [1]
C0851578
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
Beschreibung

Restless Legs Syndrome, Family History

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0241889
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
Beschreibung

Limb movement, Sleep, Family History

Datentyp

text

Alias
UMLS CUI [1,1]
C0596840
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0241889
Are the patient’s current symptoms mainly present ...
Beschreibung

Restless Legs Syndrome; Symptoms; Temporal periods of day

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0439548
RLS Diagnostic Criteria
Beschreibung

RLS Diagnostic Criteria

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0679228
The International RLS Study Group Criteria* defines RLS patients as having a desire to move the limbs usually associated with paresthesias or dysesthesias.
Beschreibung

Restless Legs Syndrome, limb movement, desire; Restless Legs Syndrome, Paresthesia; Restless Legs Syndrome, Dysesthesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0596840
UMLS CUI [1,3]
C0871633
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0030554
UMLS CUI [3,1]
C0035258
UMLS CUI [3,2]
C0392699
The International RLS Study Group Criteria* defines RLS patients as having motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort).
Beschreibung

Restless Legs Syndrome, Motor Restlessness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0700075
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
Beschreibung

Restless Legs Syndrome, Symptoms, Rest; Restless Legs Syndrom, Physical activity, Feeling relief

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0035253
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C0564405
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse in the evening or night.
Beschreibung

Restless Legs Syndrome, Symptoms, Temporal periods of day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0439548
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Racial group

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height (without shoes)
Beschreibung

Body Height

Datentyp

text

Alias
UMLS CUI [1]
C0005890
Height (without shoes)
Beschreibung

Body Height

Datentyp

float

Alias
UMLS CUI [1]
C0005890
Weight (without shoes)
Beschreibung

Body Weight

Datentyp

text

Alias
UMLS CUI [1]
C0005910
Weight (without shoes)
Beschreibung

Body Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Pulse (after 5 minutes sitting)
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
Beschreibung

Systolic pressure, Sitting position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting Blood Pressure (after 5 minutes sitting) - Diastolic
Beschreibung

Diastolic blood pressure, Sitting position

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Orthostatic Vital Signs
Beschreibung

Orthostatic Vital Signs

Alias
UMLS CUI-1
C1827287
After 10 minutes semi-supine - Time Vitals Taken
Beschreibung

Semi-erect; Vital Signs Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C2826762
After 10 minutes semi-supine - Blood Pressure (systolic)
Beschreibung

Semi-erect; Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0871470
mmHg
After 10 minutes semi-supine - Blood Pressure (diastolic)
Beschreibung

Semi-erect; Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0428883
mmHg
After 10 minutes semi-supine - Pulse
Beschreibung

Semi-erect; Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
bpm
After erect for 1 minute - Time Vitals Taken
Beschreibung

Erect, Vital Signs Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C2826762
After erect for 1 minute - Blood Pressure (systolic)
Beschreibung

Erect, Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0871470
mmHg
After erect for 1 minute - Blood Pressure (diastolic)
Beschreibung

Erect, Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0428883
mmHg
After erect for 1 minute - Pulse
Beschreibung

Erect, Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0522014
UMLS CUI [1,2]
C0018810
bpm
Electrocardiogram (12 Lead)
Beschreibung

Electrocardiogram (12 Lead)

Alias
UMLS CUI-1
C0430456
Date of ECG
Beschreibung

12 lead ECG, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Were any clinically significant abnormalities detected?
Beschreibung

If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1704258
Physical Examination
Beschreibung

Physical Examination

Alias
UMLS CUI-1
C0031809
Laboratory Evaluation
Beschreibung

Laboratory Evaluation

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0220825
Date of blood sample
Beschreibung

Collection of blood specimen for laboratory procedure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beschreibung

Laboratory Procedures, Laboratory specimen identification label

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C4273937
Were any clinically significant abnormalities detected?
Beschreibung

If ’Yes’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and repeat prior to baseline.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1704258
Urine Dipstick
Beschreibung

Urine Dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschreibung

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptoms/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Datentyp

text

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy Dipstick
Beschreibung

Pregnancy Dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
If ’Yes’, please perform a pregnancy dipstick test and record result below.
Beschreibung

If ’Positive’, please record details on the Significant Medical/ Surgical History and Physical Examination and exclude the patient.

Datentyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Significant Medical/Surgical History and Physical Examination
Beschreibung

Significant Medical/Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
Beschreibung

f 'Yes' , please list below one diagnosis per line. (Please print clearly)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0489540
Diagnosis (Only in the absence of a diagnosis, record the signs and symptoms on separate lines.)
Beschreibung

Medical History, Diagnosis; History of surgical procedures, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
Year of first diagnosis (if known)
Beschreibung

Medical History, Diagnosis, Year; History of surgical procedures, Diagnosis, Year

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0439234
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0439234
Past / Ongoing
Beschreibung

Medical History, Diagnosis, Current, Past; History of surgical procedures, Diagnosis, Current, Past

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0521116
UMLS CUI [1,4]
C1444637
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0521116
UMLS CUI [2,4]
C1444637
Prior and Concomitant Medication
Beschreibung

Prior and Concomitant Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
Beschreibung

If ‘Yes’, please record details below (Please print clearly)

Datentyp

boolean

Alias
UMLS CUI [1]
C0013227
Drug Name (Trade Name Preferred)
Beschreibung

Pharmaceutical Preparations, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Total Daily Dose
Beschreibung

Pharmaceutical Preparations, Daily Dose, Total

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
Beschreibung

Pharmaceutical Preparations, Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
Start Date (be as precise as possible)
Beschreibung

Pharmaceutical Preparation, Start Date

Datentyp

date

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

Pharmaceutical Preparation, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing
Beschreibung

Pharmaceutical Preparations, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
RLS Pharmacotherapy History
Beschreibung

RLS Pharmacotherapy History

Alias
UMLS CUI-1
C0035258
UMLS CUI-2
C0013227
UMLS CUI-3
C0262926
Has the patient taken any pharmacotherapy medication for treatment of RLS?
Beschreibung

If ‘Yes’, please record details below (Please print clearly)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0262926
Drug Name (Trade Name Preferred)
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C2360065
Start Date (be as precise as possible)
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0808070
End Date
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0806020
Continuing
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0549178
Did the patient respond to the treatment? (mark one)
Beschreibung

Restless Legs Syndrome, Drug Treatment and Response to Therapy

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0150839
Did the patient tolerate the treatment? (mark one)
Beschreibung

Restless Legs Syndrome, Pharmaceutical Preparations, Physical tolerance to drug

Datentyp

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0556444
Screening Inclusion/Exclusion Criteria
Beschreibung

Screening Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C0013893
Inclusion - Patients diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the investigator should use his/her best clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
Beschreibung

Restless Legs Syndrome, Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0011900
Inclusion - Patient is ≥ 18 years old and < 80 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Inclusion - Patient has given written informed consent prior to any specific study procedures.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion - Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
Beschreibung

Restless Legs Syndrome, Daytime

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0332169
Exclusion - Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
Beschreibung

Primary Sleep Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0236991
Exclusion - Patient is suffering from a movement disorder (e.g. Parkinson's Disease, dyskinesias or dystonias).
Beschreibung

Movement Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0026650
Exclusion - Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
Beschreibung

Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
Exclusion - Patient has exhibited intolerance to ropinirole or any other dopamine agonist
Beschreibung

Ropinirole, Intolerance to substance; Dopamine Agonists, Intolerance to substance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0244821
UMLS CUI [1,2]
C1744706
UMLS CUI [2,1]
C0178601
UMLS CUI [2,2]
C1744706
Exclusion - Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening.
Beschreibung

Substance Use Disorders; Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
Exclusion - Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).
Beschreibung

Female, Childbearing Potential, Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0700589
Exclusion - Patient is a woman who has a positive pregnancy test or is lactating.
Beschreibung

Female, Pregnancy; Female, Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086287
UMLS CUI [1,2]
C0032961
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C0006147
Exclusion - Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
Beschreibung

Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
Exclusion - Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
Beschreibung

Non-Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0457432
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Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
RLS Screen History
C0035258 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Restless Legs Syndrome, Age of Onset
Item
How old was the patient at the onset of RLS?
integer
C0035258 (UMLS CUI [1,1])
C0206132 (UMLS CUI [1,2])
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Item
Did the patient start any new medication near the time of their first onset of RLS symptoms that may have caused RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Relationships
Item
If ’Yes’ please specify medication(s)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
If female, did RLS symptoms develop during pregnancy?
text
C0035258 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Restless Legs Syndrome, During, Pregnancy
Code List
If female, did RLS symptoms develop during pregnancy?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not applicable (3)
Limb movement, Sleep
Item
Has the patient ever had PLMS (Periodic Limb Movements during Sleep)?
boolean
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Limb movement, Sleep, Age of Onset
Item
How old was the patient at the onset of PLMS?
integer
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0206132 (UMLS CUI [1,3])
Alcohol consumption
Item
Does the patient drink alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption, alcohol units/week
Item
Units/week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Caffeine consumption
Item
Does the patient drink caffeine (coffee, tea, caffeinated drinks)?
boolean
C0948365 (UMLS CUI [1])
Caffeine consumption, cups of coffee consumed per day (___cups/day)
Item
Cups/day
integer
C0948365 (UMLS CUI [1,1])
C2164136 (UMLS CUI [1,2])
Sleep Disorders
Item
Does the patient have any sleep disorder as defined by DSM IV?
boolean
C0851578 (UMLS CUI [1])
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
text
C0035258 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
Restless Legs Syndrome, Family History
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of RLS?
CL Item
No  (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
text
C0596840 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Restless Legs Syndrome, Family History
Code List
Has any first degree relative (mother/father, brother/sister, son/daughter) of the patient ever been diagnosed with or had symptoms of PLMS?
CL Item
No  (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Are the patient’s current symptoms mainly present ...
text
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Restless Legs Syndrome; Symptoms; Temporal periods of day
Code List
Are the patient’s current symptoms mainly present ...
CL Item
At nightime only (1)
CL Item
In evening and nightime (2)
CL Item
Daytime, evening and nightime (3)
Item Group
RLS Diagnostic Criteria
C0035258 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
Restless Legs Syndrome, limb movement, desire; Restless Legs Syndrome, Paresthesia; Restless Legs Syndrome, Dysesthesia
Item
The International RLS Study Group Criteria* defines RLS patients as having a desire to move the limbs usually associated with paresthesias or dysesthesias.
boolean
C0035258 (UMLS CUI [1,1])
C0596840 (UMLS CUI [1,2])
C0871633 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0030554 (UMLS CUI [2,2])
C0035258 (UMLS CUI [3,1])
C0392699 (UMLS CUI [3,2])
Restless Legs Syndrome, Motor Restlessness
Item
The International RLS Study Group Criteria* defines RLS patients as having motor restlessness (during wakefulness does the patient move the limbs in attempt to relieve the discomfort).
boolean
C0035258 (UMLS CUI [1,1])
C0700075 (UMLS CUI [1,2])
Restless Legs Syndrome, Symptoms, Rest; Restless Legs Syndrom, Physical activity, Feeling relief
Item
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse or exclusively present at rest with at least partial and temporal relief by activity
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0035253 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C0564405 (UMLS CUI [2,3])
Restless Legs Syndrome, Symptoms, Temporal periods of day
Item
The International RLS Study Group Criteria* defines RLS patients as having symptoms worse in the evening or night.
boolean
C0035258 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
undefined item
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
White  (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other, specify: (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Height (without shoes)
text
C0005890 (UMLS CUI [1])
Body Height
Code List
Height (without shoes)
CL Item
cm (1)
CL Item
in (2)
Body Height
Item
Height (without shoes)
float
C0005890 (UMLS CUI [1])
Item
Weight (without shoes)
text
C0005910 (UMLS CUI [1])
Body Weight
Code List
Weight (without shoes)
CL Item
kg (1)
CL Item
lbs (2)
Body Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
Heart rate
Item
Pulse (after 5 minutes sitting)
integer
C0018810 (UMLS CUI [1])
Systolic pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
Sitting Blood Pressure (after 5 minutes sitting) - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Orthostatic Vital Signs
C1827287 (UMLS CUI-1)
Semi-erect; Vital Signs Time
Item
After 10 minutes semi-supine - Time Vitals Taken
time
C0522019 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Semi-erect; Systolic Pressure
Item
After 10 minutes semi-supine - Blood Pressure (systolic)
integer
C0522019 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Semi-erect; Diastolic blood pressure
Item
After 10 minutes semi-supine - Blood Pressure (diastolic)
integer
C0522019 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Semi-erect; Heart rate
Item
After 10 minutes semi-supine - Pulse
integer
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Erect, Vital Signs Time
Item
After erect for 1 minute - Time Vitals Taken
time
C0522014 (UMLS CUI [1,1])
C2826762 (UMLS CUI [1,2])
Erect, Systolic Pressure
Item
After erect for 1 minute - Blood Pressure (systolic)
integer
C0522014 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Erect, Diastolic blood pressure
Item
After erect for 1 minute - Blood Pressure (diastolic)
integer
C0522014 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Erect, Heart rate
Item
After erect for 1 minute - Pulse
integer
C0522014 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Electrocardiogram (12 Lead)
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time
Item
Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
12 lead ECG, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Item Group
Laboratory Evaluation
C0022885 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Procedures, Laboratory specimen identification label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C0022885 (UMLS CUI [1,1])
C4273937 (UMLS CUI [1,2])
Laboratory Procedures, Abnormality
Item
Were any clinically significant abnormalities detected?
boolean
C0022885 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
text
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine dipstick test, Test Result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Pregnancy Dipstick
C0430056 (UMLS CUI-1)
Childbearing Potential
Item
Is the patient a female of child-bearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
If ’Yes’, please perform a pregnancy dipstick test and record result below.
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Urine pregnancy test, Test Result
Code List
If ’Yes’, please perform a pregnancy dipstick test and record result below.
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Significant Medical/Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Medical History, History of surgical procedures
Item
Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Item
Diagnosis (Only in the absence of a diagnosis, record the signs and symptoms on separate lines.)
text
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
Medical History, Diagnosis, Year; History of surgical procedures, Diagnosis, Year
Item
Year of first diagnosis (if known)
integer
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0439234 (UMLS CUI [2,3])
Item
Past / Ongoing
integer
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C1444637 (UMLS CUI [2,4])
Medical History, Diagnosis, Current, Past; History of surgical procedures, Diagnosis, Current, Past
Code List
Past / Ongoing
CL Item
Past (1)
CL Item
Ongoing (2)
Item Group
Prior and Concomitant Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Pharmaceutical Preparations
Item
Has the patient taken any medication (excluding any pharmacotherapy medication for treatment of RLS) in the 3 months prior to study entry?
boolean
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations, Medication name
Item
Drug Name (Trade Name Preferred)
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total Daily Dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Disease
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Pharmaceutical Preparation, Start Date
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparation, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
RLS Pharmacotherapy History
C0035258 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
Restless Legs Syndrome, Pharmaceutical Preparations, Medical History
Item
Has the patient taken any pharmacotherapy medication for treatment of RLS?
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Medication name
Item
Drug Name (Trade Name Preferred)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Start Date
Item
Start Date (be as precise as possible)
date
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, End Date
Item
End Date
date
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Restless Legs Syndrome, Pharmaceutical Preparations, Continuous
Item
Continuing
boolean
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Did the patient respond to the treatment? (mark one)
text
C0035258 (UMLS CUI [1,1])
C0150839 (UMLS CUI [1,2])
Restless Legs Syndrome, Drug Treatment and Response to Therapy
Code List
Did the patient respond to the treatment? (mark one)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Did the patient tolerate the treatment? (mark one)
text
C0035258 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0556444 (UMLS CUI [1,3])
Restless Legs Syndrome, Drug Treatment and Response to Therapy
Code List
Did the patient tolerate the treatment? (mark one)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item Group
Screening Inclusion/Exclusion Criteria
C0013893 (UMLS CUI-1)
Restless Legs Syndrome, Diagnosis
Item
Inclusion - Patients diagnosed with RLS using IRLSSG diagnostic criteria with a history of a minimum of 15 nights of RLS symptoms during the previous month. In the case of a patient currently receiving medication for the treatment of RLS, the investigator should use his/her best clinical judgement to assess whether that patient would have suffered from a minimum of 15 nights with RLS symptoms if they had not been taking any medication.
boolean
C0035258 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Age
Item
Inclusion - Patient is ≥ 18 years old and < 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Inclusion - Patient has given written informed consent prior to any specific study procedures.
boolean
C0021430 (UMLS CUI [1])
Restless Legs Syndrome, Daytime
Item
Exclusion - Patient is suffering from RLS symptoms which require treatment during the daytime (daytime defined as 10.00 until 18.00).
boolean
C0035258 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
Primary Sleep Disorders
Item
Exclusion - Patient suffers from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g. narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
boolean
C0236991 (UMLS CUI [1])
Movement Disorders
Item
Exclusion - Patient is suffering from a movement disorder (e.g. Parkinson's Disease, dyskinesias or dystonias).
boolean
C0026650 (UMLS CUI [1])
Disease
Item
Exclusion - Patient has medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, etc.).
boolean
C0012634 (UMLS CUI [1])
Ropinirole, Intolerance to substance; Dopamine Agonists, Intolerance to substance
Item
Exclusion - Patient has exhibited intolerance to ropinirole or any other dopamine agonist
boolean
C0244821 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C0178601 (UMLS CUI [2,1])
C1744706 (UMLS CUI [2,2])
Substance Use Disorders; Substance Dependence
Item
Exclusion - Patient meets DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 6 months prior to Screening.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Female, Childbearing Potential, Contraceptive methods
Item
Exclusion - Patient is a woman, of child-bearing potential and is not practising a clinically accepted method of contraception such as oral contraception, surgical sterilisation, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant).
boolean
C0086287 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Female, Pregnancy; Female, Breast Feeding
Item
Exclusion - Patient is a woman who has a positive pregnancy test or is lactating.
boolean
C0086287 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0086287 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
Disease
Item
Exclusion - Patient has clinically significant or unstable medical conditions which in the opinion of the investigator would render the patient unsuitable for the study (e.g., symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, etc.).
boolean
C0012634 (UMLS CUI [1])
Non-Compliance
Item
Exclusion - Patient who, in the opinion of the Investigator, would be non-compliant with the visit schedule or other study procedures.
boolean
C0457432 (UMLS CUI [1])
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