Value |
Description |
German Interpretation |
Comment |
Chapter |
AW |
Abatement of event after product withdrawn |
|
|
7.12.3.22 |
BE |
Event recurred after product reintroduced |
|
|
7.12.3.22 |
LI |
Literature reports association of product with event |
|
|
7.12.3.22 |
IN |
Event occurred after product introduced |
|
|
7.12.3.22 |
EX |
Alternative explanations for the event available |
|
|
7.12.3.22 |
PL |
Effect observed when patient receives placebo |
|
|
7.12.3.22 |
TC |
Toxic levels of product documented in blood or body fluids |
|
|
7.12.3.22 |
DR |
Dose response observed |
|
|
7.12.3.22 |
SE |
Similar events in past for this patient |
|
|
7.12.3.22 |
OE |
Occurrence of event was confirmed by objective evidence |
|
|
7.12.3.22 |
OT |
Other |
|
|
7.12.3.22 |