IRLS Rating Scale
Item
Please complete the information below based on the Baseline IRLS Rating Scale. If this score is not ≥ 15, exclude the patient
integer
Patient rated scales
Item
Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire. • Medical Outcomes Study (MOS) Sleep Scale. • Profile Of Mood State (POMS) scale • Hospital Anxiety and Depression Scale (HADS)
boolean
Pulse
Item
Pulse (after 5 minutes sitting)
integer
C0232117 (UMLS CUI [1])
Blood pressure
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic / diastolic
integer
C0005823 (UMLS CUI [1])
Concomitant medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
C2347852 (UMLS CUI [1])
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
C0199171 (UMLS CUI [1])
Serious baseline events
Item
If you consider this to be a serious baseline event (SBE), please do not enter on this page but enter in the Serious Adverse Experience section (SAE) (See opposite for definitions of an SBE)
boolean
C1519255 (UMLS CUI [1])
Baseline events
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0877248 (UMLS CUI [1])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, STOP: go to SAE section and follow instructions given there
integer
C1705586 (UMLS CUI [1])
Code List
Outcome If patient died, STOP: go to SAE section and follow instructions given there
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
CL Item
[1] Intermittent (1)
Event Course
Item
Event Course, if 'intermittent' please specify No. of episodes:
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Code List
Intensity (maximum)
Item
Relationship to study procedures performed prior to randomisation
integer
C1510821 (UMLS CUI [1])
Code List
Relationship to study procedures performed prior to randomisation
CL Item
[6] Possibly related (2)
CL Item
[7] Probably unrelated (3)
CL Item
[1] Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal related to adverse event
Item
Was patient withdrawn due to this specific event?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Container numbers
Item
Container numbers:
integer
C0180098 (UMLS CUI [1])
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Item
Reading
integer
C0456984 (UMLS CUI [1,1])
C0034754 (UMLS CUI [1,2])
CL Item
Pre-Dose Reading (1)
CL Item
2 hours Post-Dose Reading (2)
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Time Vitals Taken
Item
Time Vitals Taken
date
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Aucun commentaire