Table 2.
Summary of demographics (safety population).
| Statistic | Botulism (N = 294) |
Healthy Volunteers (N = 56) |
Other 1
(N = 162) |
Total (N = 512) |
|---|---|---|---|---|
| Age Group—n (%) | ||||
| Newborn Infants (0–<28 days) | 1 (0.34) | 0 (0.00) | 1 (0.62) | 2 (0.39) |
| Infants/Toddlers (28–<2 years) | 5 (1.70) | 0 (0.00) | 1 (0.62) | 6 (1.17) |
| Children (2–<12 years) | 4 (1.36) | 0 (0.00) | 4 (2.47) | 8 (1.56) |
| Adolescents (12–<17 years) | 5 (1.70) | 0 (0.00) | 5 (3.09) | 10 (1.95) |
| Adults (18–<65 years) | 225 (76.53) | 56 (100.00) | 96 (59.26) | 377 (73.63) |
| Geriatric (>=65 years) | 46 (15.65) | 0 (0.00) | 32 (19.75) | 78 (15.23) |
| Unknown | 8 (2.72) | 0 (0.00) | 23 (14.20) | 31 (6.05) |
| Age 2 (Years) | ||||
| N | 286 | 56 | 139 | 481 |
| Mean (SD) | 46 (18.4) | 32 (9.4) | 50 (20.7) | 45 (19.0) |
| Median | 45 | 30 | 53 | 44 |
| Range (Min, Max) | (0, 92) | (19, 52) | (0, 88) | (0, 92) |
| Race—n (%) | ||||
| American Indian or Alaska Native | 23 (7.82) | 1 (1.79) | 4 (2.47) | 28 (5.47) |
| Asian | 7 (2.38) | 1 (1.79) | 9 (5.56) | 17 (3.32) |
| Black or African American | 25 (8.50) | 0 (0.00) | 9 (5.56) | 34 (6.64) |
| Native Hawaiian or Pacific Islander | 1 (0.34) | 1 (1.79) | 1 (0.62) | 3 (0.59) |
| White | 131 (44.56) | 49 (87.50) | 72 (44.44) | 252 (49.22) |
| Multiple Race | 1 (0.34) | 2 (3.57) | 0 (0.00) | 3 (0.59) |
| Not Reported | 105 (35.71) | 2 (3.57) | 67 (41.36) | 174 (33.98) |
| Sex—n (%) | ||||
| Female | 84 (28.57) | 28 (50.00) | 61 (37.65) | 173 (33.79) |
| Male | 210 (71.43) | 28 (50.00) | 100 (61.73) | 338 (66.02) |
| Not Reported | 0 (0.00) | 0 (0.00) | 1 (0.62) | 1 (0.20) |
| Ethnicity—n (%) | ||||
| Hispanic or Latino | 27 (9.18) | 28 (50.00) | 8 (4.94) | 63 (12.30) |
| Not Hispanic or Latino | 59 (20.07) | 28 (50.00) | 31 (19.14) | 118 (23.05) |
| Not Reported | 208 (70.75) | 0 (0.00) | 123 (75.93) | 331 (64.65) |
N = number of subjects in the analysis population; n = number of subjects; % = n/N × 100; SD = Standard deviation. 1 Non-botulism final diagnosis. 2 Age represents subject’s age at the time of BAT product treatment.