Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnea, diaphoresis Myocardial infarction Chest pain Dyspnea Diaphoresis Chest pain Dyspnea Diaphoresis 3 Pulmonary embolism, myocardial infarction, and congestive heart failure with chest pain, cyanosis, shortness of breath, and blood pressure decreased Pulmonary embolism Myocardial infarction Congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased 4 Chest pain, cyanosis, shortness of breath, and blood pressure decreased. Differential diagnosis includes pulmonary embolism, myocardial infarction, and congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased Chest pain Cyanosis Shortness of breath Blood pressure decreased Always include signs/ symptoms not associated with diagnosis Myocardial infarction, chest pain, dyspnea, diaphoresis, ECG changes and jaundice Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction)
Pancreatitis Neonatal disorder Record patient age in a demographic field. In addition, select LLT Neonatal disorder. 3.7 – Body Site vs. Event Specificity 3.7.1 MedDRA term includes body site and event information Example Reported LLT Selected Skin rash on face Rash on face 3.7.2 No available MedDRA term includes both body site and event information Select a term for the event, rather than a term that reflects a non-specific condition at the body site; in other words, the event information generally has priority. Example Reported LLT Selected Comment Skin rash on chest Skin rash In this instance, there is no available term for a skin rash on the chest However, medical judgment is required, and sometimes, the body site information should have priority as in the example below. Example Reported LLT Selected Comment Cyanosis at injection site Injection site reaction Cyanosis implies a generalized disorder. In this example,
Select a term for each investigation result as reported; do not “lump” together separate investigation results under an inclusive term unless reported as such. Example Reported LLT Selected Comment Abnormalities of liver function tests Abnormal liver function tests Increased alkaline phosphatase, increased SGPT, increased SGOT and elevated LDH Alkaline phosphatase increased SGPT increased SGOT increased LDH increased Select four individual terms for the investigation results. A single term such as LLT Liver function tests abnormal should not be selected 3.14.5 Investigation terms without qualifiers Terms in SOC Investigations without qualifiers may be used to record test names when entering diagnostic test data. Example Information/Reported (Verbatim) LLT Selected for Test Name Comment Cardiac output measured Cardiac output Increased blood sugar Blood glucose LLT Blood glucose increased should not be selected as it is both a test name and a result* * Enter a qualifier (e.g., “increased”) or a numeric result (if available) into the “Result” data field. 3.15 – Medication/Administration Errors, Accidental Exposures and Occupational Exposures 3.15.1 Medication/administration errors Medication errors are defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer.
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 3.26.2 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. Example Reported LLT Selected Comment Treatment of aggression in autism Aggression The products do not treat the underlying autism, thalassemia, 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 Thalassemia major, or LLT Myocardial infarction based on regional regulatory requirements. Treatment of chronic iron overload in thalassemia major Chronic iron overload Prevention of atherothrombotic events in patients with myocardial infarction prophylaxis 3.26.3 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