Table 3.
Grade | All | ||||||||
---|---|---|---|---|---|---|---|---|---|
3 | 4 | 5 | |||||||
Body System |
Adverse Event |
Arm |
N | % | N | % | N | % | N |
Infection/Febrile Neutropenia | PNEUMONIA* | SR | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 |
SRB | 3 | 4.1 | 0 | 0 | 0 | 0 | 3 | ||
Pulmonary | ARDS | SR | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 |
SRB | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
DYSPNEA | SR | 5 | 6.9 | 0 | 0 | 0 | 0 | 5 | |
SRB | 7 | 9.5 | 0 | 0 | 0 | 0 | 7 | ||
HYPOXIA | SR | 2 | 2.8 | 0 | 0 | 0 | 0 | 2 | |
SRB | 5 | 6.8 | 1 | 1.4 | 0 | 0 | 6 | ||
PNEUMOTHORAX | SR | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 | |
SRB | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 | ||
Prolonged air-leak | SR | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 | |
SRB | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
PULMONARY - Other | SR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
SRB | 1 | 1.4 | 0 | 0 | 0 | 0 | 1 | ||
Same patient could have multiple adverse events. |
Pneumonia both with and without absolute neutrophil count specified