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The numbers and proportion of subjects reporting adverse events were listed by body system.
Adverse events were classified by body system using the Medical Dictionary for Regulatory Activities (MedDRA), and tabulated based on the incidence, severity, and causality to study treatment.
Adverse events were classified by body system using MedDRA, and tabulated based on the incidence, severity, and causality to study treatment (Table 2).
Adverse events will be summarised with groupings by body system.
Level 1 groups by body system and is ideal for evaluating large aggregations of conditions.
Incidences of serious AEs grouped by body system are shown in Table 6.
Similar(29)
Most of the centers at the National In- If health pertains to those who shape social policy, the stitutes of Health are organized by body systems.
Other comparisons evaluate illness by body systems (see Additional file 1).
Baseline co-morbidities were classified by body systems into cardiovascular (33.9%), pulmonary (13.9%), endocrine (6.7%), gastrointestinal (13.6%) and central nervous system disorders (21.6%).
In the present study, we have been able to develop a multivariate model relating the physical aspect of HRQOL (as measured by the PCS of the SF-36) and all chronic conditions – grouped by body systems – of patients with multimorbidity, while taking into account the degree of severity of the health impairments evaluated with the CIRS.
195 ADRs were identified during 59 patient interviews and the study showed systematic elicitation of ADRs, organized by body systems, increased the identification of clinically relevant ADRs that may not be detected by general inquiry, although statistical differences were not assessed.
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