Table 5.
Adverse events (AEs)
| BC (n = 1364) | Non-BC (n = 6639) | |
|---|---|---|
| Number of grade 4 incidences (N) | 1064 | 2936 |
| Number of grade 5 incidences (N) | 63 | 350 |
| Number of treatment-related deaths (N) | 8 | 30 |
| Person days on study | 181664 | 633138 |
| Person years on study | 497 | 1733 |
| Grade 4 incidence ratesa | 2.1/person-year | 1.7/person-year |
| Grade 5 incidence ratesa | 0.1/person-year | 0.2/person-year |
| Treatment-related deaths incidence ratesa | 0.02/person-year | 0.02/person-year |
| Average number of grade 4 AEs per patientb | 0.8 | 0.4 |
| Average number of grade 5 AEs per patientb | 0.047 | 0.053 |
| Average number of treatment-related deathsb | 0.006 | 0.005 |
a
Incidence rate is defined as number of incidences divided by person time
b
Average number is defined as number of incidences divided by total number of patients