Reported LLT Selected Comment Unclear if the purpose is to induce weight loss or Weight loss Weight loss to treat an underweight patient Unclear if the purpose is Immunosuppression Immunosuppression to induce or to treat immunosuppression Complex indications Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances. Reported LLT Selected Comment Aggression Treatment of aggression in autism The products do not treat the underlying autism, thalassaemia, or myocardial Chronic iron Treatment of chronic infarction, but they do address the overload iron overload in associated signs/symptoms (aggression, thalassaemia major chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, Prevention of Atherothrombosis LLT Thalassaemia major, or LLT atherothrombotic prophylaxis Myocardial infarction based on regional events in patients regulatory requirements. with myocardial infarction Indications with genetic markers or abnormalities For indications that describe a genetic marker or abnormality associated with a medical condition, select a term for both the medical condition and the genetic marker or abnormality. Example Reported LLT Selected Non-small cell lung cancer Non small cell lung cancer with K-ras mutation K-ras gene mutation Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the and are synonymous in the words “prevention” “prophylaxis” context of MedDRA). Example
Reported LLT Selected Comment Weight loss Weight loss Unclear if the purpose is to induce weight loss or to treat an underweight patient Immunosuppression Immunosuppression Unclear if the purpose is to induce or to treat immunosuppression Complex indications Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances. Reported LLT Selected Comment Treatment of aggression in autism Aggression The products do not treat the underlying autism, thalassaemia, or myocardial infarction, but they do address the associated signs/symptoms (aggression, chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, LLT Thalassaemia major, or LLT Myocardial infarction based on regional regulatory requirements. Treatment of chronic iron overload in thalassaemia major Chronic iron overload Prevention of atherothrombotic events in patients with myocardial infarction Atherothrombosis prophylaxis Indications with genetic markers or abnormalities For indications that describe a genetic marker or abnormality associated with a medical condition, select a term for both the medical condition and the genetic marker or abnormality. Example Reported LLT Selected Non small cell lung cancer with K-ras mutation Non-small cell lung cancer K-ras gene mutation Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words “prevention” and “prophylaxis” are synonymous in the context of MedDRA). Example
000240_termselptc_r4_16_sep2018_rl.docx