General Appearance
Not done
boolean
Normal
boolean
Abnormal
text
abnormality clinically significant
boolean
Skin and mucous membranes
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
one or more patches of dermatitis affecting any of the following sites: behind the knees, fronts of ankles, fronts of elbows (antecubital fossae), sides or front of the neck, or around the ears or eyes. Dermatitis may be defined as 'poorly demarcated erythema with surfacing change'. Surface change can mean scalling, crusting, vesicles or lichenification.
boolean
Eyes
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
Funduscopic exam
funduscopic exam and clearance by an ophthalmologist or a similarly qualified healthcare provider is required within 3 months prior to the screening visit or within the screening period for all subjects with diabetes mellitus, hypertension, or known retinal disorders.
boolean
normal
boolean
abnormal
text
if yes, subject is screening failure
boolean
date of funduscopic exam
integer
Ears, nose, throat
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
Cardiovascular system
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant?
boolean
Respiratory system
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
Gastrointestinal system
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
Genito-urinary system
not done
boolean
normal
boolean
abnormal
text
is the abnormality clinically significant?
boolean
neurological system
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
musculo-skeletal system
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
lymph nodes
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
anorectal
not done
boolean
normal
boolean
abnormal
text
abnormality clinically significant
boolean
other abnormality
new finding only please only one abnormality per row
text
abnormality clinically significant
boolean
row number
text