Table 2. Treatment-Emergent Adverse Events.
| Events | No. (%) of participants | |
|---|---|---|
| Therapeutic drug monitoring (n = 227) | Standard therapy (n = 227) | |
| Serious adverse eventsa | 16 (7) | 18 (8) |
| Adverse events | 137 (60) | 142 (63) |
| Most frequent adverse eventsb | ||
| Upper respiratory tract infectionc | 70 (31) | 58 (26) |
| Rash | 9 (4) | 14 (6) |
| Gastroenteritis | 8 (4) | 8 (4) |
| Herpes virus infection | 8 (4) | 4 |
| Pneumonia | 8 (4) | 4 |
| Most frequent serious adverse eventsd | ||
| Bacterial infectione | 3 (1) | 3 (1) |
| Bone fracture | 1 (<1) | 3 (1) |
| Acute appendicitis | 2 (1) | 1 (<1) |
| Choledocholithiasis | 1 (<1) | 2 (1) |
An adverse event was defined as an unfavorable and unintended sign, symptom, or disease temporally associated with use of the study drug; assessed continuously throughout the study. A serious adverse event was defined as an adverse event resulting in death, a life-threatening condition, hospitalization (initial or prolonged), disability, or permanent damage; assessed continuously throughout the study.
Most frequent adverse events were defined as occurring in more than 5% of the study population.
Upper respiratory tract infection includes common cold, nasopharyngitis, rhinitis, and sinusitis.
Most frequent serious adverse events were defined as occurring in 3 or more patients.
Bacterial infection includes pneumonia (n = 2), liver abscess (n = 1), endocarditis (n = 1), tonsillitis (n = 1), and lower urinary tract infection (n = 1).