Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
No Advers Experiences
Item
If no adverse experiences occurred during the study, please sign form below and mark this box
boolean
C0877248 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Serious adverse experience
Item
Serious adverse experience
text
C1519255 (UMLS CUI [1])
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Onset Data and Time
Item
Onset Data and Time
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
End Date and Time (if ongoing please leave blank)
Item
End Date and Time (if ongoing please leave blank)
datetime
C2981425 (UMLS CUI [1])
Item
Outcome- If patient died, STOP: go to SAE section and follow instructions given here
text
C1705586 (UMLS CUI [1])
Code List
Outcome- If patient died, STOP: go to SAE section and follow instructions given here
Item
Experience Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
CL Item
Intermittent (number of episodes:..............) (1)
Common Toxicity Grade
Item
Common Toxicity Grade: 1-4
text
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
text
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (5)
CL Item
Dose delayed and decreased (7)
Item
Relationship to Investigational Drug
text
C0439849 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (2)
Corrective Therapy
Item
If ´Yes´ record details in the Concomitant Medication section
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawn due to this specific AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Investigators Signature
Item
Investigators Signature
text
C2346576 (UMLS CUI [1])
Investigators Signature Date
Item
Investigators Signature Date
date
C0807937 (UMLS CUI [1])