Centre Number
Item
Centre Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Reminder laboratory test results
Item
Reminder laboratory test results: Ensure that the clinically significant laboratory values question on page 8 has been answered.
text
Sitting blood pressure (systolic)
Item
Sitting blood pressure (systolic)
integer
Sitting blood pressure (diastolic)
Item
Sitting blood pressure (diastolic)
integer
Sitting heart rate
Item
Sitting heart rate
integer
Experience
Item
Experience
text
Date Started
Item
Date Started
date
Date stopped
Item
Date stopped
date
Duration if less than 24hrs
Item
Duration if less than 24hrs
float
Experience continuing at end of Baseline Visit
Item
Experience continuing at end of Baseline Visit
boolean
Course
Item
Course: Continuous
boolean
Course (nr. of episodes)
Item
Course: If No, no of episodes
integer
Item
Corrective therapy
text
Code List
Corrective therapy
CL Item
Yes (If "Yes" record any medication on Concomitant Medication form) (1)
Serious Baseline Adverse Experience
Item
Do you consider this a serious baseline adverse experience by the Baseline Adverse Experience Definitions
boolean
Item
Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
text
Code List
Has the patient been compliant with study medication? (Compliance is defined as taking between approximately 80%-120% of medication)
CL Item
No (If "No" the patient is not eligible to continue in the study.) (1)