Vital signs
after 5min sitting
integer
after 5 minutes sitting
integer
after 5 minutes sitting
integer
Concomitant Medication
Adverse reaction
Medical procedures
Laboratory evaluation
Please take a blood sample if any abnormality was detected at the final on therapy visit or at withdrawal.
date
Laboratory label
text
If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module
boolean
Urine dipstick
Please perform a urine dipstick if any abnormality was detected at the final on therapy visit or at withdrawal. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.
integer
Study medication and compliance record
Specify 1 - 8
integer
First Dose Date
date
Date last dose
date
Number of tablets dispensed
integer
Number of tablets returned
integer
Dose changes
Study Medication Week number
integer
Specify 1 - 8
integer
First Dose Date
date
Date last dose
date
Number of tablets dispensed
integer
Number of tablets returned
integer
Medical procedures
If 'Yes', please record details below using standard medical terminology
integer
Medical procedures
Procedure
text
All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.
text
Procedure Start Date
date
End Date Procedure
date
Concomitant medication
Concomitant medication
Drug name
text
eg. 500 mg
text
Any new medical illness/diagnosis (or symptoms in the absence of a diagnosis) should be recorded in the Adverse Experiences and/or SAE sections as appropriate using the same terminology.
text
start date of medication
date
End Date of medication
date
If a medication was marked ‘Continuing’ at a previous visit, but has since had a dosage change or has been stopped, it must be recorded as a change below with the new start and end date.
boolean
Adverse experience (non-serious)
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column. If you consider this to be a serious adverse experience (SAE), please do not enter on this page but enter in the Serious Adverse Experience (SAE) section (See opposite for definitions of an SAE).
boolean
Adverse experience (non-serious)
Record any adverse experiences (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way since starting the treatment or since the last visit?” Provide the diagnosis, not symptoms, where possible. One adverse experience per column.
text
Adverse Event Start Date Time
datetime
(If ongoing please leave blank)
datetime
If patient died, STOP: go to SAE section and follow instructions given there
integer
adverse event course
integer
only answer if previous answer was 'intermittent'
integer
Intensity concerning the maximum
integer
Action Taken with Respect to Investigational Drug
integer
Relationship to Investigational Drug
integer
f ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
integer
Was patient withdrawn due to this specific AE?
boolean
Pregnancy information
Study conclusion
If 'No' please mark the primary cause of withdrawal.
boolean
Reason
integer
Only answer, if you chose 'other' reason for not completing the study.
text
Investigator signature
I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.
text
Investigator signature date
date