Results
A total of 90 ADR involving 64 patients were included in the analyses.
Patients presented a median age of 63 years (IQR: 51.0-70.8) and were
predominantly male (51.6%). Descriptive data and agreement analyses of
ADR were presented in Table 1 . Twelve different types of
clinical manifestations were found, resulting from 30 suspected drugs to
cause ADR. Most patients presented only one ADR (n=45; 70.3%). Thirteen
patients presented two ADR (20.3%) and five patients presented three
ADR (7.8%) during the follow up. Maximal number of ADR per patient was
four, identified in only one patient (1.6%). Mean ADR duration was
three days, and 13 ADR (14.4%) lasted for more than five days.
A total of 270 assessments were performed using the WHO-UMC system, as a
result of the evaluation of 90 ADR by the three judges involved in the
adjudication process. According to global (majority) classification, 47
(52.2%) ADR were categorized as possible and 37 (41.1%) as probable.
Conditional and unlikely were classified in three (3.3%) and two
(2.2%) cases, respectively. Only one ADR was classified as definite.
Similar categorization of the ADR, according to Naranjo algorithm was
also presented in Table 1.
Slight agreement was found in the comparison of all judges in the
pairwise analysis, and also for multiple judges, indicating poor
reproducibility of WHO-UMC system (Table 1) . Thirteen cases
were classified as unassessable by at least one judge and they were
excluded for kappa analysis.
More than a half of the studied cases of ADR were categorized by the
judges with some level of preventability. ADR was considered definitely
preventable in 29 (32.2%) cases and probably preventable in 23 (25.6%)
cases. Thirteen eight (42.2%) cases of ADR were considered not
preventable by the participating judges. Kappa Fleiss also revealed a
slight concordance among the judges (k=0.134; CI 95%: 0.018-0.225).