Retinopathy due to diabetes Diabetic retinopathy Rash with itching Itchy rash When to into more than one MedDRA term “split” If the reported ARs/AEs provides more clinical information, select more than “splitting” one MedDRA term. Example Reported LLT Selected Diarrhoea Diarrhoea and vomiting Vomiting Wrist fracture Wrist fracture due to fall Fall Exercise medical judgment so that information is not lost when a reported “splitting” 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 LLT Traumatic haematoma is more appropriate than LLT Haematoma (LLT Traumatic haematoma Animal bite Haematoma due to an to HLT Non-site animal bite Traumatic haematoma specific injuries NEC and HLT Haemorrhages NEC while LLT Haematoma links only to HLT Haemorrhages NEC)
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)
000156_termselptc_r4_15_mar2018_rl.docx