Glossary
AE (adverse event)
any untoward medical occurrence in a clinical study patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (An adverse event is thus not necessarily an adverse drug reaction (side effect).)
Approved indication
the condition or symptom for which the product is licensed; for the purpose of this registry, licensing in the European Union provides the basis for classification as approved.
APRS
all-patients-randomised set; all randomised patients.
APTS
all-patients-treated set; all patients who took at least one dose of investigational medicinal product.
Completed trial
for the purposes of this web-site, a trial for which LPLV has occurred.
Clinical confirmatory efficacy and safety trials
an adequately controlled trial in which the hypotheses are stated in advance and evaluated. Confirmatory trials are necessary to provide firm evidence of efficacy or safety (ICHE9).
FAS
full-analysis set; all patients in the APTS who had at least one valid post-baseline assessment of the primary efficacy variable.
FPFV
first patient first visit
LPLV
last patient last visit; refers to the last pre-specified follow-up visit in a trial.
Non-approved indication
a condition or symptom for which the product is not licensed, including those indications for which approval has not yet been sought or given, or which fail to obtain approval; for the purpose of this registry, licensing in the European Union provides the basis for classification as approved.
Ongoing trial
for the purposes of this web-site, a trial for which LPLV has not yet occurred.
Patient
when not otherwise specified, all patients are at least 18 years of age.
SAE (serious adverse event)
any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalisation or prolongation of existing hospitalisation (except pregnancy); results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is judged medically important.
Start date
is the date of the FPFV.
Title
this is the brief title, providing information on product, condition, and trial design.
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