Table 2. Comparing the Rates of Adverse Events Between Patients With PHACE Syndrome and Patients Without PHACE.
| Adverse Event | Patients, No. (%) | |
|---|---|---|
| With PHACE Syndrome (n = 76) | Without PHACE Syndrome (n = 726) | |
| Grade 1 | ||
| Sleep disturbance | 13 (17.1) | 55 (7.6) |
| Gastrointestinal tract | 7 (9.2) | 8 (1.1) |
| Respiratory tract | 4 (5.3) | 9 (1.2) |
| Cold extremities | 4 (5.3) | 47 (6.5) |
| Hypotension | 3 (3.9) | 4 (0.6) |
| Seizure | 2 (2.6) | 0 |
| Bradycardia | 1 (1.3) | 1 (0.1) |
| Hypoglycemia | 1 (1.3) | 2 (0.3) |
| Other | 1 (1.3) | 11 (1.5) |
| Grade 2 | ||
| Respiratory | 4 (5.3) | 15 (2.1) |
| Gastrointestinal | 3 (3.9) | 11 (1.5) |
| Sleep disturbance | 2 (2.6) | 23 (3.2) |
| Other | 1 (1.3) | 11 (1.5) |
| Grade 3 (serious adverse events) | 0 | 3 (0.4)a |
Abbreviation: PHACE, posterior fossa malformations, hemangioma, arterial anomalies, cardiac defects, and eye anomalies.
a
Serious adverse events among patients without PHACE syndrome included 1 grade 3 respiratory event and 2 grade 3 hypoglycemic events.