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.
RRequiredOOptionalCConditionalWWithdrawn|#Date/Time*Backward compat.+Filler
25
| C.Len | Element | v2.2 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ..60 | - | CE | O | * | - | 01073 | PEO-1 | Event Identifiers Used | NEW |
| 2 | ..60 | - | CE | O | * | - | 01074 | PEO-2 | Event Symptom/Diagnosis Code | NEW |
| 3 | ..26 | - | TS | R | 1 | - | 01075 | PEO-3 | Event Onset Date/Time | NEW |
| 4 | ..26 | - | TS | O | 1 | - | 01076 | PEO-4 | Event Exacerbation Date/Time | NEW |
| 5 | ..26 | - | TS | O | 1 | - | 01077 | PEO-5 | Event Improved Date/Time | NEW |
| 6 | ..26 | - | TS | O | 1 | - | 01078 | PEO-6 | Event Ended Data/Time | NEW |
| 7 | ..106 | - | XAD | O | 1 | - | 01079 | PEO-7 | Event Location Occurred Address | NEW |
| 8 | ..1 | - | ID | O | * | 0237 | 01080 | PEO-8 | Event Qualification | NEW |
| 9 | ..1 | - | ID | O | 1 | 0238 | 01081 | PEO-9 | Event Serious | NEW |
| 10 | ..1 | - | ID | O | 1 | 0239 | 01082 | PEO-10 | Event Expected | NEW |
| 11 | ..1 | - | ID | O | * | 0240 | 01083 | PEO-11 | Event Outcome | NEW |
| 12 | ..1 | - | ID | O | 1 | 0241 | 01084 | PEO-12 | Patient Outcome | NEW |
| 13 | ..600 | - | FT | O | * | - | 01085 | PEO-13 | Event Description From Others | NEW |
| 14 | ..600 | - | FT | O | * | - | 01086 | PEO-14 | Event From Original Reporter | NEW |
| 15 | ..600 | - | FT | O | * | - | 01087 | PEO-15 | Event Description From Patient | NEW |
| 16 | ..600 | - | FT | O | * | - | 01088 | PEO-16 | Event Description From Practitioner | NEW |
| 17 | ..600 | - | FT | O | * | - | 01089 | PEO-17 | Event Description From Autopsy | NEW |
| 18 | ..30 | - | CE | O | * | - | 01090 | PEO-18 | Cause Of Death | NEW |
| 19 | ..46 | - | XPN | O | 1 | - | 01091 | PEO-19 | Primary Observer Name | NEW |
| 20 | ..106 | - | XAD | O | * | - | 01092 | PEO-20 | Primary Observer Address | NEW |
| 21 | ..40 | - | XTN | O | * | - | 01093 | PEO-21 | Primary Observer Telephone | NEW |
| 22 | ..1 | - | ID | O | 1 | 0242 | 01094 | PEO-22 | Primary Observer’s Qualification | NEW |
| 23 | ..1 | - | ID | O | 1 | 0242 | 01095 | PEO-23 | Confirmation Provided By | NEW |
| 24 | ..26 | - | TS | O | 1 | - | 01096 | PEO-24 | Primary Observer Aware Date/Time | NEW |
| 25 | ..1 | - | ID | O | 1 | 0243 | 01097 | PEO-25 | Primary Observer’s Identity May Be Divulged | NEW |
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