TABLE 5.

Treatment-emergent adverse events leading to study drug discontinuationa

Event, body systemNo. (%) of patients reporting
Group 1 (200 mg q.i.d./ 400 mg b.i.d.) (n = 35)Group 2 (400 mg q.i.d./ 600 mg b.i.d.) (n = 31)Group 3 (800 mg b.i.d./ 800 mg q.d.) (n = 32)Total (n = 98)
Total8 (23)9 (29)7 (22)24 (24)
General disorders (condition aggravated, fever, hypoxia, multiorgan failure)2 (6)2 (6)1 (3)5 (5)
Central and peripheral nervous system disorder2 (6)1 (3)3 (9)6 (6)
Gastrointestinal system disorder1 (3)2 (6)2 (6)5 (5)
Infection (pneumonia, sepsis, septic shock, aspergillosis)1 (3)2 (6)1 (3)4 (4)
Respiratory system disorders3 (9)2 (6)1 (3)6 (6)
  • a All randomized patients reporting ≥2 events.