Table 1 |
|
Important definitions for PV (ICH guidelines [11]) |
| ADVERSE EVENT |
|
|
| Any untoward medical occurrence in a patient or clinical investigation subject administered
a pharmaceutical product and which does not necessarily have a causal relationship
with this treatment. An AE can therefore be any unfavourable and unintended sign (that
could include a clinically significant abnormal laboratory finding), symptom or disease
temporally associated with the use of a medicinal product, whether or not considered
related to the medicinal product (ICH guidelines). |
|
|
| ADVERSE DRUG REACTION |
|
|
| Any noxious and unintended responses to a medicinal product related to any dose. The
phrase "responses to a medicinal product" implies that a causal relationship between
a medicinal product and an adverse event (AE) is at least a reasonable possibility
(i.e. the relationship can not be ruled out). |
|
|
| UNEXPECTED ADVERSE DRUG REACTION |
|
|
| An adverse reaction, the nature or severity of which is not consistent with the applicable
product information (e.g. investigators brochure for an unapproved product or package
insert/summary of product characteristics for an approved product (ICH guidelines). |
|
|
| SERIOUS ADVERSE EVENT |
|
|
| Any untoward medical occurrence that at any dose: results in death; is life-threatening;
requires hospitalization (other than for drug administration) or prolongation of existing
hospitalization; results in persistent or significant disability/incapacity; or is
a congenital anomaly/birth defect and also other important medical events that jeopardise
the subject or require intervention to prevent one of the other outcomes listed in
the definition above). |
|
|
|
Talisuna et al. Malaria Journal 2006 5:50 doi:10.1186/1475-2875-5-50 |
