Table 2.
Adverse Events After Treatment (Overall and Treatment Related; Safety Analysis Set)
| LB + BUPI HCl (n = 97) | BUPI alone (n = 89) | |
|---|---|---|
| Any AE after treatment | 62 (63.9) | 50 (56.2) |
| Any treatment-related AE after treatment | 6 (6.2) | 9 (10.1) |
| Serious AE after treatment | 3 (3.1) | 3 (3.4) |
| Fatal AE after treatment | 0 (0.0) | 0 (0.0) |
| AEs after treatment occurring in >5% of patients in either group | ||
| Pruritus | 27 (27.8) | 28 (31.5) |
| Nausea | 24 (24.7) | 11 (12.4) |
| Vomiting | 12 (12.4) | 6 (6.7) |
| Headache | 6 (6.2) | 10 (11.2) |
| Dizziness | 6 (6.2) | 5 (5.6) |
| Constipation | 6 (6.2) | 4 (4.5) |
| Back pain | 3 (3.1) | 5 (5.6) |
| Rash | 5 (5.2) | 3 (3.4) |
| Treatment-related AEs after treatment occurring in patients in either groupa | ||
| Pruritus | 2 (2.1) | 8 (9.0) |
| Nausea | 3 (3.1) | 0 (0.0) |
| Vomiting | 3 (3.1) | 0 (0.0) |
| Dizziness | 1 (1.0) | 0 (0.0) |
| Back pain | 0 (0.0) | 1 (1.1) |
| Dysuria | 0 (0.0) | 1 (1.1) |
Values are the number (percentage). All AEs were recorded through day 14. AEs after treatment were recorded on or after the administration of study drug (which occurred after skin incision closure) through day 14.
Abbreviations: AE, adverse event; BUPI, bupivacaine; HCl, hydrochloride; LB, liposomal bupivacaine.
aTreatment relatedness was determined by the investigator.