Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Date of visit
Item
Screening visit performed at same date of baseline visit?
boolean
C1320303 (UMLS CUI [1])
Item
Randomisation/Inclusion of the patient
integer
C0034656 (UMLS CUI [1])
Code List
Randomisation/Inclusion of the patient
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Changes in relevant medical history since screening visit
integer
C0262926 (UMLS CUI [1])
Code List
Changes in relevant medical history since screening visit
CL Item
Yes (please specify below) (1)
Item
Body system
integer
C0262926 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
CL Item
Cardiovascular (01)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
CL Item
Surgery/Hospital Admission (06)
Diagnosis
Item
Disease/Diagnosis
text
C0011900 (UMLS CUI [1])
Start of disease or surgery
Item
Start of disease or surgery
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1628561 (UMLS CUI [2])
Start Date not known
Item
Not known
boolean
C0808070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
End of disease or surgery
Item
End of disease or surgery
date
C4019088 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
End date unknown
Item
Not known
boolean
C0806020 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Disease persistent
Item
Persistent
boolean
C0012634 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
Changes in MSA History since Screening visit (V0)
Item
Changes in MSA History since Screening visit (V0)
boolean
C0393571 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
MSA syncope
Item
Syncope
boolean
C0393571 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
MSA Orthostatic hypotension
Item
Orthostatic hypotension
boolean
C0393571 (UMLS CUI [1,1])
C0020651 (UMLS CUI [1,2])
MSA Urinary Incontinence
Item
Urinary Incontinence
boolean
C0393571 (UMLS CUI [1,1])
C0042024 (UMLS CUI [1,2])
MSA Erectile Dysfuntion
Item
Erectile Dysfuntion
boolean
C0393571 (UMLS CUI [1,1])
C2733447 (UMLS CUI [1,2])
MSA Other autonomic symptoms
Item
Other (please specify)
text
C0393571 (UMLS CUI [1,1])
C2674101 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Bradykinesia
Item
Bradykinesia
boolean
C2733447 (UMLS CUI [1,1])
C3176307 (UMLS CUI [1,2])
MSA Rigidity
Item
Rigidity
boolean
C2733447 (UMLS CUI [1,1])
C0858572 (UMLS CUI [1,2])
MSA Tremor
Item
Tremor
boolean
C2733447 (UMLS CUI [1,1])
C0040822 (UMLS CUI [1,2])
Resting tremor
Item
Resting tremor
boolean
C0234379 (UMLS CUI [1])
Postural tremor
Item
Postural tremor
boolean
C0234378 (UMLS CUI [1])
MSA Other parkinsonism symptoms
Item
other (please specify)
text
C2733447 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
MSA Gait ataxia
Item
Gait ataxia
boolean
C2732311 (UMLS CUI [1,1])
C0751837 (UMLS CUI [1,2])
MSA limb ataxia
Item
Limb ataxia
boolean
C2732311 (UMLS CUI [1,1])
C4015302 (UMLS CUI [1,2])
MSA Other cerebellar symptoms
Item
Other (please specify)
text
C2732311 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Current frequency of falls
integer
C1285588 (UMLS CUI [1])
Code List
Current frequency of falls
CL Item
several times per day (1)
CL Item
several times per week (2)
CL Item
several times per month (3)
CL Item
several times per year (4)
Psychiatric history
Item
Psychiatric history
boolean
C0748059 (UMLS CUI [1])
delusion
Item
Delusions
boolean
C0011253 (UMLS CUI [1])
Delsuions specify
Item
If yes, please specify
text
C0011253 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Hallucinations
Item
Hallucinations
boolean
C0018524 (UMLS CUI [1])
Hallucinations specify
Item
If yes, please specify.
text
C0018524 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Affective disorder
Item
Affective disorder
boolean
C0525045 (UMLS CUI [1])
Affective disorder specify
Item
If yes, please specify.
text
C0525045 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
psychiatric history other
Item
Other
boolean
C0748059 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other psychiatric history specify
Item
If yes, please specify.
text
C0748059 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Concomitant Medication
Item
Does the patient take any concomitant medication?
boolean
C2347852 (UMLS CUI [1])
Parkinson drugs
Item
Has the patient a stable regimen for at least one month for drugs acting against Parkinsonism.
boolean
C0003405 (UMLS CUI [1])
pharmaceutical preparation autonomic dysfunction
Item
Has the patient a stable regimen for at least one month for drugs acting against autonomic dysfunction.
boolean
C0013227 (UMLS CUI [1,1])
C3277919 (UMLS CUI [1,2])
antidepressant and antidementive drugs
Item
Has the patient a stable regimen for at least one month for antidepressant and antidementive drugs.
boolean
C0013227 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C0497327 (UMLS CUI [1,3])
Item
Code
integer
C0031809 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
CL Item
Cardiovascular (01)
CL Item
Genitourinary (04)
CL Item
Skeletal/Muscular (05)
physical examination finding
Item
Finding
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item
Cranial nerves
integer
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
cranial nerves examination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0558819 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Motor function
integer
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
Motor function specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0234130 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Reflexes
integer
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
Reflexes specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0436145 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Coordination
integer
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Coordination specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Sensation
integer
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Sensation specify
Item
If abnormal, specify
text
C0027853 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Date laboratory
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item
Type of laboratory procedure
integer
C0022885 (UMLS CUI [1])
Code List
Type of laboratory procedure
CL Item
Erythrocytes T/L (1)
CL Item
Leukocytes G/L (2)
CL Item
Thrombocytes G/L (3)
CL Item
Hemoglobin g/dL (4)
CL Item
GOT (AST) U/L (7)
CL Item
GPT (ALT) U/L (8)
CL Item
Bilirubin mg/dL (9)
CL Item
Creatinine mg/dL (10)
CL Item
Creatine Kinase U/L (11)
CL Item
Potassium mmol/L (12)
CL Item
Sodium mmol/L (13)
CL Item
Ferritin ng/mL (16)
CL Item
Transferrin g/dL (17)
CL Item
Albumine g/dL (18)
CL Item
Total protein g/dL (19)
Laboratory procedure value
Item
Value
float
C0587081 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory result normal
Item
Normal
boolean
C0587081 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Laboratory finding significant
Item
Clinical significant
boolean
C0456984 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Laboratory finding not significant
Item
Clinically not significant
boolean
C0587081 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Laboratory test not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
Item
Speech
integer
C0037817 (UMLS CUI [1])
Item
Swallowing
integer
C0392678 (UMLS CUI [1])
Item
Handwritting
integer
C0018582 (UMLS CUI [1])
Item
Cutting food and handling utensils
integer
C3639844 (UMLS CUI [1])
Code List
Cutting food and handling utensils
Item
Dressing
integer
C3639845 (UMLS CUI [1])
Item
Hygiene
integer
C3639846 (UMLS CUI [1])
Item
Walking
integer
C0080331 (UMLS CUI [1])
Item
Falling
text
C3639848 (UMLS CUI [1])
Item
Orthostatic symptoms
integer
C3203485 (UMLS CUI [1])
Code List
Orthostatic symptoms
Item
Urinary function
integer
C0871563 (UMLS CUI [1])
Code List
Urinary function
Item
Sexual function
integer
C0260667 (UMLS CUI [1])
Code List
Sexual function
Item
Bowel function
integer
C1290944 (UMLS CUI [1])
Item
Facial expression
integer
C0015457 (UMLS CUI [1])
Code List
Facial expression
Item
integer
C0037817 (UMLS CUI [1])
Item
Ocular motor dysfunction
integer
C0234130 (UMLS CUI [1])
Code List
Ocular motor dysfunction
Item
Tremor at rest
integer
C0234379 (UMLS CUI [1])
Item
Action tremor
integer
C0234376 (UMLS CUI [1])
Item
Increased tone
integer
C0026841 (UMLS CUI [1])
Item
Rapid alternating movements of hands
integer
C3166247 (UMLS CUI [1,1])
C3166248 (UMLS CUI [1,2])
Code List
Rapid alternating movements of hands
Item
Finger taps
integer
C3827716 (UMLS CUI [1,1])
C3827717 (UMLS CUI [1,2])
Item
Leg agility
integer
C3827710 (UMLS CUI [1,1])
C3827711 (UMLS CUI [1,2])
Item
Heel-knee-skin test
integer
C0278160 (UMLS CUI [1])
Code List
Heel-knee-skin test
Item
Arising from chair
integer
C1290946 (UMLS CUI [1,1])
C3639721 (UMLS CUI [1,2])
Code List
Arising from chair
Item
Posture
integer
C0426976 (UMLS CUI [1])
Item
Body sway
integer
C0870214 (UMLS CUI [1])
Item
Gait
integer
C0016928 (UMLS CUI [1])
Item
Body position
integer
C1262869 (UMLS CUI [1])
CL Item
Standing (2min) (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
vital signs Unable to record
Item
Unable to record
boolean
C0518766 (UMLS CUI [1])
Item
MRI at Baseline
text
C0024485 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Code List
MRI at Baseline
Date of MRI
Item
Date of MRI
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Trial medication distribution
integer
C3854006 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Code List
Trial medication distribution
Date of study drug distribution
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1512806 (UMLS CUI [1,3])
Number of Capsules dispensed
Item
Number of Capsules dispensed
integer
C0013227 (UMLS CUI [1,1])
C0805077 (UMLS CUI [1,2])
Planned medication start
Item
Planned medication start
date
C1521826 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])