Patient had decreased effect Drug effect decreased from drug A Patient had prolonged effect Drug effect prolonged from drug A 3.24 Social Circumstances – 3.24.1 Use of terms in this SOC Terms in SOC Social circumstances represent social factors and may be suitable to record social and medical history data. Such terms are not generally suitable for recording ARs/AEs; however, in certain instances, terms in SOC Social circumstances are the only available terms for recording ARs/AEs or may add valuable clinical information. Example Reported LLT Selected Patient’s ability to drive was impaired Impaired driving ability Terms in SOC Social circumstances are not multi-axial and, unlike terms in other in MedDRA (e.g., SOC Gastrointestinal disorders), they “disorder” SOCs generally refer to a person, not to a medical condition. Be aware of the impact that terms in SOC Social circumstances may have on data retrieval, analysis and reporting as illustrated in the table below: Term in SOC Social circumstances Similar term in “Disorder” SOC (“person”) (“condition”) Alcoholic Alcoholism Drug abuser Drug abuse Drug addict Drug addiction Glue sniffer Glue sniffing Smoker Nicotine dependence Note that terms not associated with drugs/substances are in this SOC*, “abuse” regardless of whether they refer to the person or to the condition, as illustrated in the table below: LLT PT Child abuse Child abuse Child abuser
Patient had decreased effect from drug A Drug effect decreased Patient had prolonged effect from drug A Drug effect prolonged 3.24 – Social Circumstances 3.24.1 Use of terms in this SOC Terms in SOC Social circumstances represent social factors and may be suitable to record social and medical history data. Such terms are not generally suitable for recording ARs/AEs; however, in certain instances, terms in SOC Social circumstances are the only available terms for recording ARs/AEs or may add valuable clinical information. Example Reported LLT Selected Patient’s ability to drive was impaired Impaired driving ability Terms in SOC Social circumstances are not multi-axial and, unlike terms in other “disorder” SOCs in MedDRA (e.g., SOC Gastrointestinal disorders), they generally refer to a person, not to a medical condition. Be aware of the impact that terms in SOC Social circumstances may have on data retrieval, analysis and reporting as illustrated in the table below: Term in SOC Social circumstances (“person”) Similar term in “Disorder” SOC (“condition”) Alcoholic Alcoholism Drug abuser Drug abuse Drug addict Drug addiction Glue sniffer Glue sniffing Smoker Nicotine dependence Note that “abuse” terms not associated with drugs/substances are in this SOC*, regardless of whether they refer to the person or to the condition, as illustrated in the table below: LLT PT Child abuse Child abuse Child abuser
9491-1600_termselptc_r4_5_mar2013.docx