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])
Person Reporting SAE
Item
Person Reporting SAE (Please print clearly)
text
C0335038 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C3828190 (UMLS CUI [1])
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalization (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalization prolonged (5)
CL Item
congenital abnormality (6)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
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, please complete Form D
text
C1705586 (UMLS CUI [1])
Code List
Outcome- If patient died, please complete Form D
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)
SAE Abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Study medication reintroduced
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)
boolean
C3854006 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
If Yes to study medication reintroduced (or dose increased)
Item
If Yes to study medication reintroduced (or dose increased), did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
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)
Item
What is the SAE probably associated with ?
text
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
What is the SAE probably associated with ?
CL Item
Protocol design or procedures (but not to study drug) -Please specify:....................... (1)
CL Item
Another Condition (eg, condition under study, intercurrent illness) -Please specify:....................... (2)
CL Item
Another Drug -Please specify:....................... (3)
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 SAE
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relevant Laboratory Data-Test name
Item
Relevant Laboratory Data-Test name
text
C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Relevant Laboratory Data-Date
Item
Relevant Laboratory Data - Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Relevant Laboratory Data-Value
Item
Relevant Laboratory Data-Value
text
C0022885 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Relevant Laboratory Data-Units
Item
Relevant Laboratory Data-Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Relevant Laboratory Data-Normal Range
Item
Relevant Laboratory Data-Normal Range
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant Laboratory Data-Remarks
Item
Relevant Laboratory Data-Remarks
text
C0587081 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Randomisation code broken at investigational site
Item
If applicable, was randomisation code broken at investigational site ?
boolean
C0034656 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Randomisation/Study Medication Number
Item
Randomisation/Study Medication Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (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])
Please PRINT name
Item
Please PRINT name
text
C2826892 (UMLS CUI [1])