Congenital Terms any condition present at birth, whether genetically inherited or occurring in “Congenital” = utero (see the MedDRA Introductory Guide). Congenital conditions Select terms from SOC Congenital, familial and genetic disorders when the reporter describes the condition as congenital or when medical judgment establishes that the condition was present at the time of birth. Example Reported LLT Selected Comment Congenital heart disease Heart disease congenital Child born with heart disease A term is not “congenital” available but LLT/PT Newborn with phimosis Phimosis Phimosis links to primary SOC Congenital, familial and genetic disorders Acquired conditions (not present at birth) If information is available indicating that the condition is not congenital or present at birth, i.e., it is acquired, select the non-qualified term for the condition, making sure that the non-qualified term does not link to SOC Congenital, familial and genetic disorders. If a non-qualified term is not available, select the term for the condition. “acquired” Example Reported LLT Selected Comment LLT/PT Night blindness links to primary SOC Eye disorders. Do not assume Developed night blindness Night blindness the condition is congenital in middle age (LLT/PT Congenital night blindness).
Congenital Terms “Congenital” = any condition present at birth, whether genetically inherited or occurring in utero (see the MedDRA Introductory Guide). Congenital conditions Select terms from SOC Congenital, familial and genetic disorders when the reporter describes the condition as congenital or when medical judgment establishes that the condition was present at the time of birth. Example Reported LLT Selected Comment Congenital heart disease Heart disease congenital Child born with heart disease Newborn with phimosis Phimosis A “congenital” term is not available but LLT/PT Phimosis links to primary SOC Congenital, familial and genetic disorders Acquired conditions (not present at birth) If information is available indicating that the condition is not congenital or present at birth, i.e., it is acquired, select the non-qualified term for the condition, making sure that the non-qualified term does not link to SOC Congenital, familial and genetic disorders. If a non-qualified term is not available, select the “acquired” term for the condition. Example Reported LLT Selected Comment Developed night blindness in middle age Night blindness LLT/PT Night blindness links to primary SOC Eye disorders. Do not assume the condition is congenital (LLT/PT Congenital night blindness).
000240_termselptc_r4_16_sep2018.docx