Exposures during Pregnancy and Breast Feeding To select the most appropriate exposure term (or terms), first determine if the subject/patient who experienced the event is the mother or the child/foetus. Events in the mother Pregnant patient exposed to medication with clinical consequences If a pregnancy exposure is reported with clinical consequences, select terms for both the pregnancy exposure and the clinical consequences. Example Reported LLT Selected Maternal exposure during pregnancy Pregnant patient receiving drug X experienced a pruritic rash Pruritic rash Pregnant patient exposed to medication without clinical consequences If a pregnancy exposure report specifically states that there were no clinical consequences, the preferred option is to select only a term for the pregnancy exposure. Alternatively, a term for the pregnancy exposure and the additional LLT No adverse effect can be selected (see Section 3.21). Example Reported LLT Selected Preferred Option Maternal exposure during pregnancy Patient received drug X while Maternal exposure during pregnant (no adverse effect) pregnancy No adverse effect Events in the child or foetus Select terms for both the type of exposure and any adverse event(s). Example Setting/Patient Reported LLT Selected Pregnant taking drug X; Foetus with AE; exposed in Drug exposure in utero foetal tachycardia noted on utero; mother took product Foetal tachycardia routine examination
Exposures during Pregnancy and Breast Feeding To select the most appropriate exposure term (or terms), first determine if the subject/patient who experienced the event is the mother or the child/foetus. Events in the mother Pregnant patient exposed to medication with clinical consequences If a pregnancy exposure is reported with clinical consequences, select terms for both the pregnancy exposure and the clinical consequences. Example Reported LLT Selected Pregnant patient receiving drug X experienced a pruritic rash Maternal exposure during pregnancy Pruritic rash Pregnant patient exposed to medication without clinical consequences If a pregnancy exposure report specifically states that there were no clinical consequences, the preferred option is to select only a term for the pregnancy exposure. Alternatively, a term for the pregnancy exposure and the additional LLT No adverse effect can be selected (see Section 3.21). Example Reported LLT Selected Preferred Option Patient received drug X while pregnant (no adverse effect) Maternal exposure during pregnancy Maternal exposure during pregnancy No adverse effect Events in the child or foetus Select terms for both the type of exposure and any adverse event(s). Example Setting/Patient Reported LLT Selected Foetus with AE; exposed in utero; mother took product Pregnant taking drug X; foetal tachycardia noted on routine examination Drug exposure in utero Foetal tachycardia
000012_termselptc_r4_13_mar2017_RL.docx