Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS Number
Item
AEGIS Number
integer
C0600091 (UMLS CUI [1])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Item
Reasons for considering a serious AE
integer
C1519255 (UMLS CUI [1])
Code List
Reasons for considering 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)
Onset Date and Time SAE
Item
Onset Date and Time SAE
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
End Date and Time SAE
Item
End Date and Time (if ongoing please leave blank) SAE
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome SAE
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
CL Item
Intermittend -> Please fill in No. of episodes below (1)
Number of episodes
Item
If experience course intermittent, please fill in no. of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity SAE
integer
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted restarted (4)
Abatement
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Reintroduction of product
Item
If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Recurrence of SAE
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
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
Possibly related (2)
CL Item
Probably unrelated (3)
Item
The SAE is probably associated with
integer
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
The SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug) -> please specify below (1)
CL Item
Another condition (e.g condition under study, intercurrent illness) -> please specify below (2)
CL Item
Another drug (please specify below) (3)
SAE association
Item
Please specify association
text
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Corrective Therapy SAE
Item
Corrective Therapy SAE
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Remarks SAE
Item
Remarks SAE
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of test
Item
Date of test
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Value of test
Item
Value of test
text
C1522609 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Units of test
Item
Units of test
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Range of test
Item
Normal Range of test
text
C0086715 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])