Visit Date
Was a physical examination performed?
Physical Examination
Clinical Assessment
integer
If other Clinical Assessment, please specify
text
Check one box only
integer
If clinically significant, please record on the adverse event page
text
Vital Signs
If Yes, complete below
boolean
Date of assessment
date
Check one box only
integer
Systolic BP
integer
Diastolic BP
integer
Heart Rate
integer
Respiration Rate
integer
Temperature
float
Check one box only
integer
Weight
float
Check one box only
integer
12-Lead ECG
Was a 12-lead ECG performed?
boolean
Date of ECG
date
Check one box only
integer
ECG Results
Ventriculat rate
integer
PR Interval
integer
QRS Duration
integer
QT
integer
QTc
integer
QTc Formula
integer
ECG Findings
Hematology
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
boolean
Date and time of sample
datetime
(if different from main hospital laboratory)
text
Hematology
Parameter
integer
Result
text
Units
text
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
integer
Not Done
integer
Clinical Chemistry, Coagulation and Electrolytes
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
boolean
Date and time of sample
datetime
(if different from main hospital laboratory)
text
Clinical Chemistry, Coagulation and Electrolytes
Parameter
integer
Results
text
Units
text
Check one box only. If any result is clinically significant, please record a diagnosis on the adverse event page.
integer
Not Done
integer
Urinalysis dipstick results
If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
boolean
Date of sample
date
Time of sample
time
(if different from main hospital laboratory)
text
pH
integer
If other pH, please specify
text
Glucose
integer
If other Glucose, please specify
text
Blood
integer
If other Blood, please specify
text
Protein
integer
If other Protein, please specify.
text
Leucocytes
integer
If other Leucocytes, please specify.
text
Urinalysis microscopy results
Check one box only. If No, or if results are not available, please complete details on the comments page or the protocol deviations page.
integer
Date of sample
date
Time of sample
time
If different from main hospital laboratory
text
Urinalysis microscopy results
Parameter
integer
Result
text
Units
text
Not Done
integer
Clinically significant?
boolean
Serum beta-hCG Pregnancy Test
If Yes, complete below
boolean
If a serum β-hCG pregnancy test has been performed please give details.
boolean
Date of pregnancy test
date
Check one box only
integer
PK Sampling - Plasma Samples
Check if Not Applicable
integer
Date of Sampling
date
Time of Sampling
time
Check if Not Done
integer
Study Treatment Compliance (Return)
If No, please complete the comments page or the protocol deviations page.
boolean
If No, please provide the number of missed doses and the dates that the doses were missed. If No, please complete the comments page or the protocol deviations page.
boolean
No. of missed dates:
integer
Dates dose missed:
text
New Adverse Events and Concomitant Treatment
If Yes, please record details on Adverse Events page.
boolean
If Yes, please record details on Concomitant Treatment page.
boolean