Select LLT No adverse effect Pregnancy (in addition to LLT Pregnancy (no adverse No adverse effect Pregnancy) if no effect) adverse event has occurred. (See Section 3.21) Select LLT Pregnancy Pregnancy (outcome only if neither outcome Pregnancy unknown) nor occurrence of AE is known Pregnant patient receiving medication experienced adverse event Example Reported LLT Selected Comment LLT Pregnancy can be Pregnant patient receiving Maternal exposure during selected for medical drug X experienced a pregnancy history, concomitant pruritic rash Pruritic rash medical condition 3.10.2 Events in the child or fetus Select terms for both the type of exposure and any adverse event(s). Example Setting/Patient Reported LLT Selected Pregnant woman taking drug Drug exposure in utero Fetus with AE; exposed in X; fetal tachycardia noted Fetal tachycardia utero; mother took product on routine examination Baby born with cleft palate; Paternal drug exposure Baby with AE; exposed in father had been taking before pregnancy utero; father took product drug X at time of Cleft palate conception Mother exposed to drug X; Drug exposure via Newborn with AE; exposed nursing newborn breast milk to product via breast milk experienced vomiting Vomiting neonatal
Pregnancy (no adverse effect) Pregnancy No adverse effect Select LLT No adverse effect (in addition to LLT Pregnancy) if no adverse event has occurred. (See Section 3.21) Pregnancy (outcome unknown) Pregnancy Select LLT Pregnancy only if neither outcome nor occurrence of AE is known Pregnant patient receiving medication experienced adverse event Example Reported LLT Selected Comment Pregnant patient receiving drug X experienced a pruritic rash Maternal exposure during pregnancy Pruritic rash LLT Pregnancy can be selected for medical history, concomitant medical condition 3.10.2 Events in the child or fetus Select terms for both the type of exposure and any adverse event(s). Example Setting/Patient Reported LLT Selected Fetus with AE; exposed in utero; mother took product Pregnant woman taking drug X; fetal tachycardia noted on routine examination Drug exposure in utero Fetal tachycardia Baby with AE; exposed in utero; father took product Baby born with cleft palate; father had been taking drug X at time of conception Paternal drug exposure before pregnancy Cleft palate Newborn with AE; exposed to product via breast milk Mother exposed to drug X; nursing newborn experienced vomiting Drug exposure via breast milk Vomiting neonatal
9491-1600_termselptc_r4_5_mar2013.docx