Item
Has the patient taken any concomitant medication(s) (other than study drug and medications for the treatment of Parkinson ́s Disease) from 30 days prior to screening through the end of the Treatment Period?
integer
C2347852 (UMLS CUI [1])
Code List
Has the patient taken any concomitant medication(s) (other than study drug and medications for the treatment of Parkinson ́s Disease) from 30 days prior to screening through the end of the Treatment Period?
Medication name
Item
Medication
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Date medication started
Item
Date started
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date medication stopped
Item
Date stopped
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuous
Item
Continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication dose and frequency
Item
Dose and frequency
text
C3174092 (UMLS CUI [1,1])
C3476109 (UMLS CUI [1,2])
Item
Route
integer
C0013153 (UMLS CUI [1])
CL Item
Other, Specify (9)
Specify other route of administration
Item
Specify other route of administration
text
C0205394 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Indication of medication
Item
indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Has the patient experienced any new and/or worsening adverse events from the time of screening through the end of the Treatment Period?
integer
C0877248 (UMLS CUI [1])
Code List
Has the patient experienced any new and/or worsening adverse events from the time of screening through the end of the Treatment Period?
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Serious adverse event
Item
Serious
boolean
C1519255 (UMLS CUI [1])
Start date adverse event
Item
Start date
date
C2697888 (UMLS CUI [1])
Start time adverse event
Item
Start time
time
C2697889 (UMLS CUI [1])
Stop date adverse event
Item
Stop date
date
C2697886 (UMLS CUI [1])
Stop time adverse event
Item
Stop time
time
C2826658 (UMLS CUI [1])
Item
Intensity
integer
C1710066 (UMLS CUI [1])
Item
Relationship to drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to drug
CL Item
SUSPECTED (reasonable possibility) (3)
Item
Action taken
integer
C2826626 (UMLS CUI [1])
CL Item
DOSE INCREASED (3)
CL Item
DRUG INTERRUPTED/RESTARTED (4)
Item
Corrective therapy
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective therapy
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Adverse event number of episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
RESOLVED WITH SEQUELAE (3)
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Item
Was an autopsy performed?
integer
C0004398 (UMLS CUI [1])
Code List
Was an autopsy performed?
Primary cause of death
Item
Primary cause of death
text
C0007465 (UMLS CUI [1])
Underlying causes of death
Item
Underlying cause(s) of death
text
C0007465 (UMLS CUI [1])
Item
Was death related to study drug?
integer
C0011065 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Code List
Was death related to study drug?
Signature of investigator
Item
Signature of investigator
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Person reporting SAE
Item
Person reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious adverse event
Item
Serious adverse event
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE.
integer
C0679228 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious AE.
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalization (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalization prolonged (5)
CL Item
congenital abnormality (6)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
Onset date serious adverse event
Item
Onset date
date
C2985916 (UMLS CUI [1])
Onset time serious adverse event
Item
Onset time
time
C2697889 (UMLS CUI [1])
End date serious adverse event
Item
End date
date
C2697886 (UMLS CUI [1])
End time serious adverse event
Item
End time
time
C2826658 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Course of event
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Course of event
Number of episodes serious adverse event
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
Action Taken with Respect to Study Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Study Drug
CL Item
Dose increased (3)
CL Item
Dose interrupted/restarted (4)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
drug reintroduced
Item
Was study drug reintroduced (or dose increased)?
boolean
C0013230 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
SAE reoccurence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1])
Item
Relationship to Study Drug
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Relationship to Study Drug
CL Item
Suspected (reasonable possibility) (3)
Assessment
Item
The SAE is probably associated with Protocol design or procedures (but not to study drug).
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Assessment
Item
The SAE is probably associated with another condition (eg, condition under study, concurrent illness).
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Assessment
Item
The SAE is probably associated with another drug.
boolean
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Corrective therapy
Item
Corrective therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
withdrawn due to adverse event
Item
Was patient withdrawn from the study due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Laboratory test 1
Item
Laboratory Test 1
text
C0022885 (UMLS CUI [1])
Date of laboratory test 1
Item
Date 1
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Value of laboratory test 1
Item
Value 1
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 1
Item
Units 1
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 1
Item
Normal range 1
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 2
Item
Laboratory test 2
text
C0022885 (UMLS CUI [1])
Date of laboratory test 2
Item
Date 2
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 2
Item
Value 2
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 2
Item
Unit 2
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 2
Item
Normal range 2
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 3
Item
Laboratory test 3
text
C0022885 (UMLS CUI [1])
Date of laboratory test 3
Item
Date 3
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 3
Item
Value 3
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 3
Item
Unit 3
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 3
Item
Normal range 3
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Laboratory test 4
Item
Laboratory test 4
text
C0022885 (UMLS CUI [1])
Value of laboratory test 4
Item
Value 4
float
C0587081 (UMLS CUI [1])
Date of laboratory test 4
Item
Date 4
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Unit of laboratory test 4
Item
Unit 4
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 4
Item
Normal range 4
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
SAE remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomization broken
Item
If applicable, was the randomisation code broken at the investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Investigator's print name
Item
Investigator's print name
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Date of Investigator Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])