Table 4.
Adverse eventsa.
| HRIG + Vaccine |
Comparator + Vaccine |
Overall |
|
|---|---|---|---|
| (n = 59) |
(n = 59) |
(N = 118) |
|
| no. (%) | no. (%) | no. (%) | |
| Any TEAEs | 48 (81.4) | 51 (86.4) | 99 (83.9) |
| Related TEAEs | 32 (54.2) | 27 (45.8) | 59 (50.0) |
| Serious TEAEs | 1 (1.7) | 0 | 0 |
| TEAEs leading to discontinuation of study treatment | 2 (3.4) | 0 | 2 (1.7) |
| TEAEs leading to death | 0 | 0 | 0 |
| Individual TEAEs (all causality) | |||
| Injection site pain | 29 (49.2) | 23 (39.0) | 52 (44.1) |
| Headache | 8 (13.6) | 9 (15.3) | 17 (14.4) |
| Upper respiratory tract infection | 8 (13.6) | 8 (13.6) | 16 (13.6) |
| Myalgia | 8 (13.6) | 6 (10.2) | 14 (11.9) |
| Nausea | 4 (6.8) | 2 (3.4) | 6 (5.1) |
| Dizziness | 3 (5.1) | 2 (3.4) | 5 (4.2) |
| Presyncope | 4 (6.8) | 1 (1.7) | 5 (4.2) |
| Pain in extremity | 2 (3.4) | 3 (5.1) | 5 (4.2) |
| Arthralgia | 4 (6.8) | 0 | 4 (3.4) |
| Back pain | 2 (3.4) | 2 (3.4) | 4 (3.4) |
| Fatigue | 3 (5.1) | 1 (1.7) | 4 (3.4) |
| Diarrhea | 2 (3.4) | 2 (3.4) | 4 (3.4) |
| Ecchymosis | 3 (5.1) | 1 (1.7) | 4 (3.4) |
| Laceration | 2 (3.4) | 2 (3.4) | 4 (3.4) |
| Individual TEAEs (drug-related) | |||
| Injection site pain | 25 (42.4) | 17 (28.8) | 42 (35.6) |
| Headache | 2 (3.4) | 3 (5.1) | 5 (4.2) |
| Myalgia | 1 (1.7) | 3 (5.1) | 4 (3.4) |
aHRIG = human rabies immune globulin, TEAE = treatment-emergent adverse event.