TABLE 10.
Incidence of Subjects With Adverse Events (AEs)* (Experienced by 4 or More Subjects) and Rate per Infusion, Irrespective of Causality (ITT Population)
| AE (≥4 Subjects) | All AEs* | AEs* Occurring During or Within 72 Hours of Infusion | ||
|---|---|---|---|---|
| Number (%) of subjects (n=49) | Number (rate†) of AEs (n=2264 infusions) | Number (%) of subjects (n=49) | Number (rate†) of AEs (n=2264 infusions) | |
| Local reactions‡ | 49 (100) | 1340 (0.592) | 49 (100) | 1322 (0.584) |
| Other AEs: | ||||
| Headache | 13 (26.5) | 40 (0.018) | 12 (24.5) | 32 (0.014) |
| Cough | 8 (16.3) | 9 (0.004) | 5 (10.2) | 6 (0.003) |
| Diarrhea | 7 (14.3) | 8 (0.004) | 5 (10.2) | 6 (0.003) |
| Fatigue | 6 (12.2) | 6 (0.003) | 4 (8.2) | 4 (0.002) |
| Back pain | 5 (10.2) | 11 (0.005) | 4 (8.2) | 5 (0.002) |
| Nausea | 5 (10.2) | 5 (0.002) | 4 (8.2) | 4 (0.002) |
| Abdominal pain, upper | 5 (10.2) | 5 (0.002) | 3 (6.1) | 3 (0.001) |
| Rash | 5 (10.2) | 7 (0.003) | 2 (4.1) | 3 (0.001) |
| Pain in extremity | 4 (8.2) | 7 (0.003) | 4 (8.2) | 6 (0.003) |
| Migraine | 4 (8.2) | 5 (0.002) | 3 (6.1) | 4 (0.002) |
| Pain | 4 (8.2) | 5 (0.002) | 3 (6.1) | 4 (0.002) |
| Epistaxis | 4 (8.2) | 6 (0.003) | 2 (4.1) | 3 (0.001) |
| Pharyngolaryngeal pain | 4 (8.2) | 6 (0.003) | 2 (4.1) | 2 (<0.001) |
| Arthralgia | 4 (8.2) | 5 (0.002) | 2 (4.1) | 3 (0.001) |
*
Excluding infections.
†
Rate of AEs per infusion.
‡
Includes injection-site reactions as well as bruising, scabbing, pain, irritation, cysts, eczema, and nodules at the injection site.