Flexible Dose Start Date and Current Dose Level
Vital signs
Sitting Blood Pressure
integer
Sitting Blood Pressure
integer
Sitting Heart Rate
integer
Concomitant Medication
Adverse Experiences
Transcribe any ongoing adverse experiences from the previous module, record any changes to ongoing adverse experiences, and details of any new adverse experiences observed or reported by the patient in the Adverse Experiences section towards the back of this module.
boolean
Study Medication Compliance
Compliance is defined as taking between approximately 80-120% of medication.
integer
End of visit instructions for patients continuing
text
End of visit constructions for patients not continuing
text
Concomitant medication
Permitted Concomitant medication
text
Transcribe any ongoing concomitant medication from the previous module, and record any concomitant medication changes since the last visit. Any new medical illness/diagnosis or symptoms in the absence of a diagnosis should be recorded in the Adverse Experience section utilising the same terminology. lf a medication was marked 'Continuing' at the last visit, but has since had a dosage change or has been stopped, it must be recorded as a change with the start and end date.
boolean
Details of Concomitant Medication
Drug Name
text
Total Daily Dose
integer
Medical Condition
text
Approximate Start Date
date
End Date
date
Continuing
boolean
For SB
text
Levodopa rescue
Patients must complete as a minimum the initial dose level 5. Titration of the dose of study medication to the maximum tolerated dose is encouraged. However if the patient´s symptoms remain inadequately controlled, open label L-dopa may be prescribed as a rescue medication.
text
Levodopa - Rescue Therapy
text
Levodopa - Rescue Therapy
text
Primary reason
text
Details of Ledopa Rescue Therapy
Adverse Experiences
Details on adverse experiences
Experience
text
For SB
text
Date started
date
Date stopped
date
Duration if if less than 24 hrs
integer
Experience continuing
boolean
Course
boolean
Number of episodes
integer
Intensity
text
Action taken on Study Medication
text
Suspected relationship
text
Corrective therapy
integer
Serious adverse experience
boolean
AEGIS
text
Investigator´s signature
text
Patient Continuation/Withdrawal
Patient Continuation/Withdrawal
integer
Most appropriate reason for withdrawal
integer
Specification of other
text
Date of last dose
date
Investigator´s signature
text
Date
date