This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.
Study Type
OBSERVATIONAL
Enrollment
24
Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Site Reference ID/Investigator# 35862
Aichi, Japan
Site Reference ID/Investigator# 35863
Okayama, Japan
Site Reference ID/Investigator# 35864
Osaka, Japan
Site Reference ID/Investigator# 35865
Tokyo, Japan
Number of Patients With Adverse Drug Reactions (ADRs)
The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
Time frame: During pregnancy and for one year after birth
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Site Reference ID/Investigator# 5326
Tokyo, Japan