TABLE 12.
Most Frequent (≥1% of Infusions in Any Group) Temporally Associated Adverse Events in PIDD Patients Treated With Privigen® for Up to 124 Weeks
| Adverse Event | Number (%*) of Temporally Associated AEs | |
|---|---|---|
| Low Max. Infusion Rate 8 mg/kg/min 423 Infusions | High Max. Infusion Rate 12 mg/kg/min 265 Infusions | |
| Headache | 54 (12.8) | 2 (0.8) |
| Pain† | 23 (5.4) | 4 (1.5) |
| Nausea | 8 (1.9) | 2 (0.8) |
| Chills | 7 (1.7) | 0 (0) |
| Vomiting | 4 (0.9) | 0 (0) |
| Pyrexia | 9 (2.1) | 1 (0.4) |
*
Percentage of infusions associated with each AE (i.e., number of AEs divided by number of infusions).
†
Includes the following AE preferred terms: pain, abdominal pain, abdominal pain lower, abdominal pain upper, back pain, chest pain, infusion site pain, injection site pain, neck pain, pain in extremity, urinary tract pain, pharyngolaryngeal pain, and ear pain.
Source: Adapted from Sleasman 2010.