Table 5.

Adverse events and adverse drug reactions in patients with risk factors (safety population)

ParameterAdverse events for groupAdverse drug reactions for group
Total (n = 42)300 mg (n = 21)600 mg (n = 21)Total (n = 42)300 mg (n = 21)600 mg (n = 21)
No. of events824438211110
No. of patients (%)31 (73.8)15 (71.4)16 (76.2)14 (33.3)6 (28.6)8 (38.1)
95% CI (%)58.0, 86.147.8, 88.752.8, 91.819.6, 49.511.3, 52.218.1, 61.6
P value (for Peramivir 300 mg)1.00000.7442
Adverse event clinical symptom [no. (%)]
    Diarrhea2 (4.8)1 (4.8)1 (4.8)1 (2.4)0 (0.0)1 (4.8)
    Pneumonia3 (7.1)1 (4.8)2 (9.5)0 (0.0)0 (0.0)0 (0.0)
    Oral herpes infection3 (7.1)1 (4.8)2 (9.5)0 (0.0)0 (0.0)0 (0.0)
Abnormal laboratory value change [no. (%)]
    Blood glucose increased10 (23.8)6 (28.6)4 (19.0)3 (7.1)2 (9.5)1 (4.8)
    Eosinophil count increased4 (9.5)3 (14.3)1 (4.8)1 (2.4)1 (4.8)0 (0.0)
    Glucose urine present4 (9.5)1 (4.8)3 (14.3)0 (0.0)0 (0.0)0 (0.0)
    Neutrophil count decreased5 (11.9)4 (19.0)1 (4.8)3 (7.1)3 (14.3)0 (0.0)
    Protein total decreased4 (9.5)3 (14.3)1 (4.8)1 (2.4)1 (4.8)0 (0.0)
    White blood cells urine positive3 (7.1)2 (9.5)1 (4.8)0 (0.0)0 (0.0)0 (0.0)
    Blood phosphorus decreased4 (9.5)2 (9.5)2 (9.5)1 (2.4)1 (4.8)0 (0.0)
  • Note: Only events that occurred more than 3.times are included in the list.