Table 3.
Adverse drug reactions by SOC classification.a
| Adverse drug reaction | Serious adverse drug reaction | |
|---|---|---|
| Exposure, PYs | 711.8 | 711.8 |
| All | 76.1 | 18.3 |
| Infections and infestations | 19.9 | 6.6 |
| General disorders and administration-site conditions | 14.3 | 0.8 |
| Gastrointestinal disorders | 10.3 | 4.5 |
| Skin and subcutaneous tissue disorders | 9.8 | 0.6 |
| Investigations | 3.8 | 0.7 |
| Nervous system disorders | 3.4 | 1.0 |
| Respiratory, thoracic, and mediastinal disorders | 3.0 | 0.3 |
| Hepatobiliary disorders | 2.5 | 0.3 |
| Infections of interest | ||
| Nasopharyngitis | 2.5 | |
| Pharyngitis | 1.8 | |
| Pneumoniab | 1.8 | 1.3 |
| Bronchitis | 1.7 | |
| Herpes zoster | 1.4 | 0.4 |
| Anal abscess | 1.1 | 0.8 |
| Sepsisc | 0.8 | 0.8 |
| Abdominal abscess | 0.6 | 0.4 |
| Gastrointestinal disorders of interest | ||
| Ileusd | 1.4 | 1.3 |
| Intestinal obstruction | 0.8 | 0.8 |
SOC, system organ class; PY, person-years.
aEvents per 100 patient-years [PYs].
bIncluding Pseudomonas pneumonia and bacterial pneumonia.
cIncluding Pseudomonas sepsis.
dIncluding subileus disorders.