| Value |
Description |
German Interpretation |
Comment |
Chapter |
| AW |
Abatement of event after product withdrawn |
|
|
2.C.2.102 |
| BE |
Event recurred after product reintroduced |
|
|
2.C.2.102 |
| LI |
Literature reports association of product with event |
|
|
2.C.2.102 |
| IN |
Event occurred after product introduced |
|
|
2.C.2.102 |
| EX |
Alternative explanations for the event available |
|
|
2.C.2.102 |
| PL |
Effect observed when patient receives placebo |
|
|
2.C.2.102 |
| TC |
Toxic levels of product documented in blood or body fluids |
|
|
2.C.2.102 |
| DR |
Dose response observed |
|
|
2.C.2.102 |
| SE |
Similar events in past for this patient |
|
|
2.C.2.102 |
| OE |
Occurrence of event was confirmed by objective evidence |
|
|
2.C.2.102 |
| OT |
Other |
|
|
2.C.2.102 |