Patient experience
Item
1. Has the patient experienced any of the following since randomization:
text
Dizziness or Lightheadedness
Item
Dizziness or Lightheadedness
boolean
Fainting
Item
Fainting
boolean
C0039070 (UMLS CUI [1])
Headache
Item
Headache during first week of study drug administration
boolean
Item
If headache occurred please indicate how it was treated (indicate all that apply):
integer
Code List
If headache occurred please indicate how it was treated (indicate all that apply):
CL Item
Down titration of study medication A (2)
Outcome Events or Serious Adverse Events
Item
2. Have any Outcome Events or Serious Adverse Events been experienced? (See instructions on facing page)
boolean
Item
if "Yes" please indicate all that apply
integer
Code List
if "Yes" please indicate all that apply
CL Item
Myocardial Infarction (2)
CL Item
New or worsening congestive heart failure (CHF) (4)
CL Item
Other designated vascular event (5)
CL Item
Hemorrhagic Event (6)
CL Item
Thrombotic Thrombocytopenia purpura (7)
CL Item
Newly diagnosed diabetes (9)
Signature of Investigator or Sub-Investigator
Item
4. Signature of Investigator or Sub-Investigator
text
Date of Signature
Item
Date of Signature (dd mon yy)
date