Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE
integer
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious AE
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalisation (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalisation prolonged (5)
CL Item
congenital abnormality (6)
CL Item
investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
SAE Onset Date and Time
Item
SAE Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
SAE End Date and Time
Item
SAE End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
SAE Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
If Intermittent Course, record Number of episodes
Item
If Intermittent Course, record Number of episodes
integer
C0750729 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
Common Toxicity Grade
Item
Common Toxicity Grade
integer
C2826262 (UMLS CUI [1])
Item
Action Taken with Respect to Investigational Drug
integer
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 & decreased (7)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0420247 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1611744 (UMLS CUI [2])
C0580673 (UMLS CUI [3])
If medication was reintroduced dose increased, did SAE recur?
Item
If medication was reintroduced dose increased, did SAE recur?
boolean
C0304229 (UMLS CUI [1])
C1611744 (UMLS CUI [2])
C0580673 (UMLS CUI [3])
C1519255 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
Item
Relationship to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (2)
Item
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is probably associated with
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
If Relationship to Investigational Drug is "Not related" or "Unlikely", the SAE is 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)
Specify protocol designs or prodcedures
Item
Specify protocol designs or prodcedures
text
C1507083 (UMLS CUI [1])
C2700391 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Specify Another Condition
Item
Specify Another Condition
text
C0348080 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Specify Another drug
Item
Specify Another drug
text
C1115771 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
Corrective therapy
Item
Corrective therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient 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])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
If applicable, was randomisation code broken at investigational site?
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C3899531 (UMLS CUI [1,2])
Please print name
Item
Please print name
text
C0027365 (UMLS CUI [1])
SB Medical Monitor's Signature
Item
SB Medical Monitor's Signature
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Test
Item
Test
text
C0022885 (UMLS CUI [1])
Test Date
Item
Test Date
date
C2826247 (UMLS CUI [1])
Test Value
Item
Test Value
float
C0587081 (UMLS CUI [1])
Test Units
Item
Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])