Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnoea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnoea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnoea, diaphoresis Myocardial infarction pain Dyspnoea Diaphoresis Chest pain Dyspnoea 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 Pulmonary embolism
Reported LLT Selected Comment Hospitalisation due to congestive failure Congestive heart failure Record hospitalisation as an outcome If the only information reported is the patient outcome, select the most specific term available. Example Reported LLT Selected Patient was hospitalised Hospitalisation Suicide and Self-Harm Accurate and consistent term selection for reports of suicide attempts, completed suicides, and self-harm is necessary for data retrieval and analysis. If the motive for reported injury is not clear, seek clarification from the source. If overdose is reported Do not assume that an overdose – including an intentional overdose – is a suicide attempt. Select only the appropriate overdose term (see Section 3.18). If self-injury is reported For reports of self-injury that do not mention suicide or suicide attempt, select only the appropriate self-injury term. Example Reported LLT Selected Comment Self slashing Self inflicted laceration LLT Self inflicted laceration is linked to PT Intentional self-injury Cut her own wrists Cut wrists in a suicide attempt Self inflicted laceration Suicide attempt Took an overdose in an attempt to commit suicide Intentional overdose Suicide attempt If overdose is reported in the context of suicide or a suicide attempt, the more specific LLT Intentional overdose can be selected (see also Section 3.18)
Retinopathy due to diabetes Diabetic retinopathy Rash with itching Itchy rash When to “split” into more than one MedDRA term If “splitting” the reported ARs/AEs provides more clinical information, select more than one MedDRA term. Example Reported LLT Selected Diarrhoea and vomiting Diarrhoea Vomiting Wrist fracture due to fall Wrist fracture Fall Exercise medical judgment so that information is not lost when “splitting” a reported term. Always check the MedDRA hierarchy above the selected term to be sure it is appropriate for the reported information. Example Reported LLT Selected Comment Haematoma due to an animal bite Animal bite Traumatic haematoma LLT Traumatic haematoma is more appropriate than LLT Haematoma (LLT Traumatic haematoma to HLT Non-site specific injuries NEC and HLT Haemorrhages NEC while LLT Haematoma links only to HLT Haemorrhages NEC)
Investigation results consistent with diagnosis When investigation results are reported with a diagnosis, select only a term for the diagnosis if investigation results are consistent with the diagnosis. Example Reported LLT Selected Comment Elevated potassium, K 7.0 mmol/L, and hyperkalaemia Hyperkalaemia It is not necessary to select LLT Potassium increased Investigation results not consistent with diagnosis When investigation results are reported with a diagnosis, select a term for the diagnosis and also select terms for any investigation results that are not consistent with the diagnosis. Example Reported LLT Selected Comment Alopecia, rash, and elevated potassium 7.0 mmol/L Alopecia Rash Potassium increased Elevated potassium is not consistent with the diagnoses of alopecia and rash. for all concepts should be selected. Grouped investigation result terms 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
Example Reported LLT Selected Pharmacist stole medications from the pharmacy and sold them to others for recreational use Drug diversion A person put a sedative into the patient’s drink Drug diversion Inadvertent exposure to drug Transmission of Infectious Agent via Product If a report of transmission of an infectious agent via a product is received, select a term for the transmission. If the infection is identified, select a second term for the specific infection; if appropriate, a product quality issue term can also be selected (see Section 3.28). Example Reported LLT Selected Patient received a nasal spray product and later developed a severe nasal infection with Burkholderia cepacia. Cultures of unopened containers of the nasal spray grew B. cepacia Transmission of an infectious agent via product Product contamination bacterial Burkholderia cepacia infection Patient received a blood transfusion and developed Hepatitis C Transfusion-transmitted infectious disease Hepatitis C Medical judgment should be used if the reporter does not explicitly state transmission of an infectious agent via a product but this could be implied by other data within the report. In this instance, select LLT Suspected transmission of an infectious agent via product. Overdose, Toxicity and Poisoning Accidental overdose terms are grouped under HLT Product administration errors and issues; other overdose terms are grouped under HLT Overdoses NEC. Toxicity and poisoning terms are grouped under HLT Poisoning and toxicity. For more information, refer to the MedDRA Introductory Guide.