Table 5.
Preferred Term |
Lot Group 1 (N = 377) n (%) [events] |
Lot Group 2 (N = 375) n (%) [events] |
Lot Group 3 (N = 377) n (%) [events] |
Overall (N = 1129) n (%) [events] |
---|---|---|---|---|
Upper respiratory tract infection | 19 (5.0) [19] | 25 (6.7) [26] | 21 (5.6) [23] | 65 (5.8) [68] |
Injection site nodule | 11 (2.9) [11] | 10 (2.7) [10] | 12 (3.2) [12] | 33 (2.9) [33] |
Blood potassium increased | 6 (1.6) [6] | 11 (2.9) [11] | 10 (2.7) [10] | 27 (2.4) [27] |
Injection site discoloration | 3 (0.8) [3] | 5 (1.3) [5] | 7 (1.9) [7] | 15 (1.3) [15] |
Injection site bruising | 5 (1.3) [5] | 4 (1.1) [4] | 3 (0.8) [3] | 12 (1.1) [12] |
Urinary tract infection | 1 (0.3) [1] | 4 (1.1) [4] | 4 (1.1) [4] | 9 (0.8) [9] |
Vaccination site bruising | 2 (0.5) [2] | 3 (0.8) [4] | 2 (0.5) [2] | 7 (0.6) [8] |
Anxiety | 2 (0.5) [2] | 2 (0.5) [2] | 2 (0.5) [3] | 6 (0.5) [7] |
Ligament sprain | 4 (1.1) [4] | 1 (0.3) [1] | 1 (0.3) [1] | 6 (0.5) [6] |
Pyrexia | 0 | 3 (0.8) [3] | 3 (0.8) [3] | 6 (0.5) [6] |
Abbreviations: N = number of subjects in the specified group; n = number of subjects reporting an adverse event in the specified Preferred Term category.