Section 3.20) 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 should Pregnant patient receiving Drug exposure during also be selected for drug X experienced a pregnancy medical history, pruritic rash Pruritic rash 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 Pregnant woman taking drug Fetus with AE; exposed in Fetal tachycardia X; fetal tachycardia noted utero; mother took product Drug exposure in utero on routine examination Baby born with cleft palate; Cleft palate Baby with AE; exposed in father had been taking Paternal drug exposure utero; father took product drug X at time of before pregnancy conception Vomiting neonatal Mother exposed to drug X; Drug exposure via Newborn with AE; exposed nursing newborn breast milk (See to product via breast milk experienced vomiting Section 3.15.3, Accidental exposures)
Section 3.20) 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 Drug exposure during pregnancy Pruritic rash LLT Pregnancy should also 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 Fetal tachycardia Drug exposure in utero Baby with AE; exposed in utero; father took product Baby born with cleft palate; father had been taking drug X at time of conception Cleft palate Paternal drug exposure before pregnancy Newborn with AE; exposed to product via breast milk Mother exposed to drug X; nursing newborn experienced vomiting Vomiting neonatal Drug exposure via breast milk (See Section 3.15.3, Accidental exposures)