TABLE 4

Comparison of AE and ADE Rates

StudyAEs per 100 PatientsADEs per 100 PatientsAEs per 1000 Patient-DaysADEs per 1000 Patient-Days
Current study36.725.076.349.8
Matlow et al615.1
Takata et al (Phase 1)159.813.4
Takata et al (Phase 2)1511.115.7
Holdsworth et al246
Kaushal et al252.3