PEO

Product Experience Observation

Details related to a particular clinical experience or event are embodied in the PEO segment. This segment can be used to characterize an event which might be attributed to a product to which the patient was exposed. Products with a possible causal relationship to the observed experience are described in the following PCR (possible causal relationship) segments. The message format was designed to be robust and includes many optional elements which may not be required for a particular regulatory purpose but allow a complete representation of the drug experience if needed.

A PEX message can contain multiple PEO segments if the patient experienced more than one event but must contain at least one PEO segment.

25
C.LenElementv2.6
1--CWEO*999901073PEO-1Event Identifiers UsedLength
2--CWEO*999901074PEO-2Event Symptom/Diagnosis CodeLength
3--DTMR1-01075PEO-3Event Onset Date/TimeLength
4--DTMO1-01076PEO-4Event Exacerbation Date/TimeLength
5--DTMO1-01077PEO-5Event Improved Date/TimeLength
6--DTMO1-01078PEO-6Event Ended Data/TimeLength
7--XADO*-01079PEO-7Event Location Occurred AddressLength
81-IDO*023701080PEO-8Event QualificationMin Length
91-IDO1023801081PEO-9Event SeriousMin Length
101-IDO1023901082PEO-10Event ExpectedMin Length
111-IDO*024001083PEO-11Event OutcomeMin Length
121-IDO1024101084PEO-12Patient OutcomeMin Length
13-600=FTO*-01085PEO-13Event Description from Others2
14-600=FTO*-01086PEO-14Event Description from Original Reporter2
15-600=FTO*-01087PEO-15Event Description from Patient2
16-600=FTO*-01088PEO-16Event Description from Practitioner2
17-600=FTO*-01089PEO-17Event Description from Autopsy2
18--CWEO*999901090PEO-18Cause Of DeathLength
19--XPNO*-01091PEO-19Primary Observer NameLength
20--XADO*-01092PEO-20Primary Observer AddressLength
21--XTNO*-01093PEO-21Primary Observer TelephoneLength
221-IDO1024201094PEO-22Primary Observer's QualificationMin Length
231-IDO1024201095PEO-23Confirmation Provided ByMin Length
24--DTMO1-01096PEO-24Primary Observer Aware Date/TimeLength
251..2-IDO1024301097PEO-25Primary Observer's identity May Be Divulged2
Used In Message Structures