TABLE 3.
Numbers of adverse events by severity and cohorta
Reactogenicity | Cohort 1 (N = 17) |
Cohort 2 (N = 15) |
Cohort 3 (N = 15) |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Severity |
Severity |
Severity |
||||||||||
None (n [%]) | Mild (n [%]) | Moderate (n [%]) | Severe (n [%]) | None (n [%]) | Mild (n [%]) | Moderate (n [%]) | Severe (n [%]) | None (n [%]) | Mild (n [%]) | Moderate (n [%]) | Severe (n [%]) | |
Fever | 16 (94.1) | 0 (0) | 1 (5.9) | 0 (0) | 13 (86.7) | 2 (13.3) | 0 (0) | 0 (0) | 13 (86.7) | 1 (6.7) | 1 (6.7) | 0 (0) |
Headache | 9 (52.9) | 6 (35.3) | 2 (11.8) | 0 (0) | 9 (60.0) | 5 (33.3) | 1 (6.7) | 0 (0) | 6 (40.0) | 8 (53.3) | 0 (0) | 1 (6.7) |
Malaise | 11 (64.7) | 5 (29.4) | 1 (5.9) | 0 (0) | 13 (86.7) | 2 (13.3) | 0 (0) | 0 (0) | 9 (60.0) | 5 (33.3) | 0 (0) | 1 (6.7) |
Abdominal pain | 13 (76.5) | 2 (11.8) | 1 (5.9) | 1 (5.9) | 11 (73.3) | 4 (26.7) | 0 (0) | 0 (0) | 10 (66.7) | 4 (26.7) | 1 (6.7) | 0 (0) |
Nausea | 5 (29.4) | 11 (64.7) | 1 (5.9) | 0 (0) | 9 (60.0) | 6 (40.0) | 0 (0) | 0 (0) | 8 (53.3) | 6 (40.0) | 1 (6.7) | 0 (0) |
Vomiting | 11 (64.7) | 5 (29.4) | 1 (5.9) | 0 (0) | 12 (80.0) | 3 (20.0) | 0 (0) | 0 (0) | 14 (93.3) | 1 (6.7) | 0 (0) | 0 (0) |
Shortness of breath | 16 (94.1) | 1 (5.9) | 0 (0) | 0 (0) | 14 (93.3) | 1 (6.7) | 0 (0) | 0 (0) | 15 (100.0) | 0 (0) | 0 (0) | 0 (0) |
Dizziness | 10 (58.8) | 7 (41.2) | 0 (0) | 0 (0) | 13 (86.7) | 2 (13.3) | 0 (0) | 0 (0) | 12 (80.0) | 3 (20.0) | 0 (0) | 0 (0) |
Rash | 15 (88.2) | 2 (11.8) | 0 (0) | 0 (0) | 13 (86.7) | 2 (13.3) | 0 (0) | 0 (0) | 13 (86.7) | 1 (6.7) | 1 (6.7) | 0 (0) |
Urticaria | 16 (94.1) | 1 (5.9) | 0 (0) | 0 (0) | 15 (100.0) | 0 (0) | 0 (0) | 0 (0) | 14 (93.3) | 1 (6.7) | 0 (0) | 0 (0) |
Bloody stools | 17 (100.0) | 0 (0) | 0 (0) | 0 (0) | 14 (93.3) | 1 (6.7) | 0 (0) | 0 (0) | 14 (93.3) | 1 (6.7) | 0 (0) | 0 (0) |
Any of the above symptoms | 4 (23.5) | 9 (52.9) | 3 (17.6) | 1 (5.9) | 5 (33.3) | 9 (60.0) | 1 (6.7) | 0 (0) | 3 (20.0) | 8 (53.3) | 3 (20.0) | 1 (6.7) |
N, number of subjects in population; n, number of subjects with at least one occurrence of an adverse event in the specified category.