Table 2. Common Adverse Events Occurring in ≥ 5% of Subjects in any Study Group - Safety Population.
| MedDRA System Organ Class Preferred Term |
AV7909; AV7909;Plc (N=44) n (%) |
AV7909;Plc; AV7909 (N=34) n (%) |
AV7909 × 3 (N=23) n (%) |
½ dose AV7909 × 3 (N=44) n (%) |
BioThrax × 3 (N=23) n (%) |
|---|---|---|---|---|---|
|
Subjects with any
adverse event |
36 (81.8) | 26 (76.5) | 17 (73.9) | 35 (79.5) | 15 (65.2) |
| Cardiac Disorders | 3 (6.8) | 1 (2.9) | 2 (8.7) | 5 (11.4) | 0 |
| Bradycardia | 2 (4.5) | 0 | 1 (4.3) | 5 (11.4) | 0 |
|
Infections and
Infestations |
19 (43.2) | 13 (38.2) | 5 (21.7) | 15 (34.1) | 4 (17.4) |
| Nasopharyngitis | 7 (15.9) | 3 (8.8) | 0 | 2 (4.5) | 1 (4.3) |
| Upper respiratory tract infection |
10 (22.7) | 5 (14.7) | 2 (8.7) | 7 (15.9) | 2 (8.7) |
| Urinary tract infection | 0 0 | 1 (2.9) | 2 (8.7) | 1 (2.3) | 0 |
| Viral infection | 1 (2.3) | 2 (5.9) | 0 | 2 (4.5) | 0 |
| Vulvovaginal mycotic infection |
0 | 0 | 0 | 0 | 2 (18.2)a |
| Investigations | 19 ( 43.2) | 13 (38.2) | 9 (39.1) | 19 (43.2) | 7 (30.4) |
| Aspartate aminotransferase increased |
2 (4.5) | 2 (5.9) | 1 (4.3) | 1 (2.3) | 0 |
| Blood pressure diastolic decreased |
5 ( 11.4) | 3 (8.8) | 2 (8.7) | 6 (13.6) | 0 |
| Blood pressure increased |
3 (6.8) | 0 | 0 | 0 | 0 |
| Heart rate decreased | 1 (2.3) | 4 (11.8) | 0 | 1 (2.3) | 2 (8.7) |
| Protein urine present | 0 | 0 | 0 | 0 | 2 (8.7) |
| Red blood cells urine positive |
2 (4.5) | 0* | 0 | 0* | 4 (17.4) |
| Respiratory rate increased |
6 (13.6) | 2 (5.9) | 4 (17.4) | 10 (22.7) | 2 (8.7) |
|
Musculoskeletal and
Connective Tissue Disorders |
3 (6.8) | 5 (14.7) | 2 (8.7) | 5 ( 11.4) | 0 |
| Back pain | 2 (4.5) | 2 (5.9) | 0 | 2 (4.5) | 0 |
|
Respiratory, Thoracic
and Mediastinal Disorders |
3 (6.8) | 5 (14.7) | 3 (13.0) | 2 (4.5) | 3 (13.0) |
| Oropharyngeal pain | 1 (2.3) | 2 (5.9) | 1 (4.3) | 2 (4.5) | 0 |
| Pharyngeal erythema | 0 | 0 | 2 (8.7) | 0 | 0 |
MedDRA=Medical Dictionary for Regulatory Activities; Plc=placebo.
Adverse events were assessed at every study visit after signing informed consent from Screening through Day 84.
All adverse events occurring prior to receipt of investigational product are excluded from this table.
Adverse events were coded using MedDRA version 15.1.
a
The denominator for this gender-specific AE term is the number of women.
*
P < 0.05 for comparison with the BioThrax group (Fisher’s Exact test; analysis performed post hoc).