Example More Than One LLT Selected There is no single MedDRA term for gingival cancer”. Therefore, the options “metastatic are: Select LLT Gingival cancer OR LLT Metastatic carcinoma Select LLT Gingival cancer AND LLT Metastatic carcinoma Check the Hierarchy When considering selecting an LLT, check the hierarchy above the LLT (PT level and further up the hierarchy to HLT, HLGT and SOC) to ensure the placement accurately reflects the meaning of the reported term. Select Terms for All Reported Information, Do Not Add Information Select terms for every AR/AE reported, regardless of causal association. In addition, select terms for device-related events, product quality issues, medication errors, medical history, social history, investigations, and indications as appropriate. If a diagnosis is reported with characteristic and symptoms, the preferred option is to select a term for the diagnosis only (see Section 3.1 for details and examples). When selecting terms, no reported information should be excluded from the term selection process; similarly, do not add information by selecting a term for a diagnosis if only signs or symptoms are reported. Example Reported LLT Selected Comment It is inappropriate to Abdominal pain Abdominal pain, increased assign an LLT serum amylase, and Serum amylase increased for diagnosis increased serum lipase Lipase increased of “pancreatitis” TERM SELECTION POINTS Definitive and Provisional Diagnoses with or without Signs and Symptoms The table below provides term selection options for definitive and provisional diagnoses with or without signs/symptoms reported. Examples are listed below the table. A provisional diagnosis may be described as of”, “suspicion “probable”, “presumed”, likely”, out”, etc. “rule “questionable”, “differential”,
Example More Than One LLT Selected There is no single MedDRA term for “metastatic gingival cancer”. Therefore, the options are: Select LLT Gingival cancer OR LLT Metastatic carcinoma Select LLT Gingival cancer AND LLT Metastatic carcinoma Check the Hierarchy When considering selecting an LLT, check the hierarchy above the LLT (PT level and further up the hierarchy to HLT, HLGT and SOC) to ensure the placement accurately reflects the meaning of the reported term. Select Terms for All Reported Information, Do Not Add Information Select terms for every AR/AE reported, regardless of causal association. In addition, select terms for device-related events, product quality issues, medication errors, medical history, social history, investigations, and indications as appropriate. If a diagnosis is reported with characteristic and symptoms, the preferred option is to select a term for the diagnosis only (see Section 3.1 for details and examples). When selecting terms, no reported information should be excluded from the term selection process; similarly, do not add information by selecting a term for a diagnosis if only signs or symptoms are reported. Example Reported LLT Selected Comment Abdominal pain, increased serum amylase, and increased serum lipase Abdominal pain It is inappropriate to assign an LLT for diagnosis of “pancreatitis” Serum amylase increased Lipase increased TERM SELECTION POINTS Definitive and Provisional Diagnoses with or without Signs and Symptoms The table below provides term selection options for definitive and provisional diagnoses with or without signs/symptoms reported. Examples are listed below the table. A provisional diagnosis may be described as “suspicion of”, “probable”, “presumed”, likely”, “rule out”, “questionable”, “differential”, etc.
000012_termselptc_r4_13_mar2017.docx