|
Code
|
Description
|
Comment
|
Version
|
| AW
|
Abatement of event after product withdrawn |
|
added v2.3 |
| BE
|
Event recurred after product reintroduced |
|
added v2.3 |
| DR
|
Dose response observed |
|
added v2.3 |
| EX
|
Alternative explanations for the event available |
|
added v2.3 |
| IN
|
Event occurred after product introduced |
|
added v2.3 |
| LI
|
Literature reports association of product with event |
|
added v2.3 |
| OE
|
Occurrence of event was confirmed by objective evidence |
|
added v2.3 |
| OT
|
Other |
|
added v2.3 |
| PL
|
Effect observed when patient receives placebo |
|
added v2.3 |
| SE
|
Similar events in past for this patient |
|
added v2.3 |
| TC
|
Toxic levels of product documented in blood or body fluids |
|
added v2.3 |