Prulifloxacin Effectiveness in Moderate-to-Severe Acute Exacerbations of Chronic Bronchitis: Α Noninterventional, Multicentre, Prospective Study in Real-Life Clinical Practice—The “AIOLOS” Study

Table 3

Incidence of adverse events.

Adverse events, N = 305	Events	n (%)
At least one adverse event	16	14 (4.6)
Chronic obstructive pulmonary disease	3	3 (1.0)
Diarrhoea	2	2 (0.7)
Pneumonia	2	2 (0.7)
Bronchitis	1	1 (0.3)
Condition aggravated	1	1 (0.3)
Death	1	1 (0.3)
Fatigue	1	1 (0.3)
Gastrointestinal disorder	1	1 (0.3)
Headache	1	1 (0.3)
Nausea	1	1 (0.3)
Vomiting	1	1 (0.3)
Plasma cell myeloma	1	1 (0.3)
At least one serious adverse event	7	6 (2.0)
Chronic obstructive pulmonary disease^a	2	2 (0.7)
Pneumonia^a	2	2 (0.7)
Plasma cell myeloma^a	1	1 (0.3)
Diarrhoea	1	1 (0.3)
Death	1	1 (0.3)
At least one adverse event assessed to be related to prulifloxacin	4	4 (1.3)
At least one serious adverse event assessed to be related to prulifloxacin	2	2 (0.7)
Diarrhoea	1	1 (0.3)
Death	1	1 (0.3)
At least one nonserious adverse event assessed to be related to prulifloxacin	2	2 (0.7)
Diarrhoea	1	1 (0.3)
Headache	1	1 (0.3)

^aThe four patients who experienced these events were hospitalized. One patient experienced two serious adverse events, namely, pneumonia and plasma cell myeloma.