Table 5.

Summary of adverse events and adverse drug reactions (safety population)

ParameteraValue for group
PeramivirOseltamivir (n = 365)
300 mg (n = 364)600 mg (n = 364)
AEs
    Total
        No. of AEs272288297
        No. (% [95% CI]) of patients with ≥1170 (46.7 [41.5, 52.0])174 (47.8 [42.6, 53.1])178 (48.8 [43.5, 54.0])
        P0.60400.8242
    Mild
        No. of mild AEs909095
        No. (%) of patients with ≥169 (19.0)66 (18.1)74 (20.3)
    Moderate
        No. of moderate AEs161166177
        No. (%) of patients with ≥1119 (32.7)116 (31.9)121 (33.2)
    Severe
        No. of severe AEs213225
        No. (%) of patients with ≥119 (5.2)30 (8.2)24 (6.6)
ADRs
    Total
        No. of ADRs8099104
        No. (% [95% CI]) of patients with ≥151 (14.0 [10.6, 18.0])66 (18.1 [14.3, 22.5])73 (20.0 [16.0, 24.5])
        P0.03820.5718
    Mild
        No. of mild ADRs404248
        No. (%) of patients with ≥129 (8.0)32 (8.8)40 (11.0)
    Moderate
        No. of moderate ADRs374747
        No. (%) of patients with ≥129 (8.0)34 (9.3)37 (10.1)
    Severe
        No. of severe ADRs3109
        No. (%) of patients with ≥13 (0.8)10 (2.7)9 (2.5)
No. (%) of patients with the following AEb:
    Neutrophil count decreased39 (10.7)38 (10.4)34 (9.3)
    Diarrhea24 (6.6)30 (8.2)27 (7.4)
    Protein present in urine17 (4.7)16 (4.4)22 (6.0)
    Blood glucose increased11 (3.0)14 (3.8)12 (3.3)
    Urine positive for WBCs14 (3.8)8 (2.2)16 (4.4)
    Nausea8 (2.2)8 (2.2)20 (5.5)
    Vomiting2 (0.5)6 (1.6)15 (4.1)
No. (%) of patients with the following ADRb:
    Diarrhea14 (3.8)20 (5.5)19 (5.2)
    Neutrophil count decreased9 (2.5)14 (3.8)13 (3.6)
    Nausea2 (0.5)7 (1.9)16 (4.4)
  • a AEs, adverse events; ADRs, adverse drug reactions; WBCs, white blood cells. P values were calculated by intergroup comparison between the peramivir and oseltamivir groups using Fisher's exact test.

  • b Data are shown only for AEs or ADRs that occurred at a frequency of >3% in any of the three groups.