Table 3 |
|
|
Relationship of adverse events to antimalarial agents |
|
| Classification |
Definition |
|
|
|
| Definitely related |
Events have no uncertainty in their relationship to test drug administration: meaning
that a re-challenge was positive. |
| Probable |
The suspected adverse event follows a reasonable temporal sequence from study drug
administration, abates upon discontinuation of the drug, and cannot be reasonably
explained by the known characteristics of the subject's clinical state. |
| Possible |
The suspected adverse event may or may not follow a reasonable temporal sequence from
study drug administration but seems to be the type of reaction that cannot be dismissed
as unlikely. The event could have been produced or mimicked by the subject's clinical
state or by other modes of therapy concomitantly administered to the subject. |
| Unlikely |
There is no reasonable temporal association between the study drug and the suspected
event and the event could have been produced by the subject's clinical state or other
modes of therapy administered to the subject. |
| Definitely unrelated |
Events which occur prior to test drug administration or for those events which cannot
be even remotely related to study participation (e.g. injury caused by a third party). |
|
|
|
|
Talisuna et al. Malaria Journal 2006 5:50 doi:10.1186/1475-2875-5-50 |
|
