3.2 Signal detection at PT level
A combination of PRR and ROR algorithms was utilized to analyze AEs and
assess their adherence to various screening criteria. In the FAERS
database, a total of 150 PTs related to pirfenidone was screened, and
the top 20 PTs, presented in Figure 2, are ranked by their lower 95% CI
values. The top five robust PTs were idiopathic pulmonary fibrosis
(lower 95% CI: 52.21), lung diffusion test decreased (lower 95% CI:
48.29), forced vital capacity decreased (lower 95% CI: 36.64), forced
vital capacity abnormal (lower 95% CI: 35.99), and sunburn (lower 95%
CI: 30.91). And 422 PTs related to nintedanib were identified, and the
top five strongest PTs were idiopathic pulmonary fibrosis (lower 95%
CI: 978.10), oxygen saturation increased (lower 95% CI: 88.89), cough
decreased (lower 95% CI: 86.22), oxygen consumption (lower 95% CI:
49.93), and lung transplant (lower 95% CI: 48.95) (Figure 3). In the
VigiAccess database, the top 20 PTs were ranked by case numbers. The top
five PTs for pirfenidone were death (case number: 6240), nausea (case
numbers: 5013), fatigue (case number: 3760), decreased appetite (case
number: 3733), diarrhoea (case number: 2895) (Table 1). And the top five
PTs for nintedanib were diarrhoea (case numbers: 9676), nausea (case
number: 3770), weight decreased (case number: 2888), decreased appetite
(case number: 2671), vomiting (case number: 2302).