Table 1.
Baseline demographics and clinical characteristics of evaluable subjects.
| Characteristic | CVT-E002 | Placebo | p-value |
|---|---|---|---|
|
| |||
| # (%) | # (%) | ||
| Total | 137 (100) | 143 (100) | |
| Age | .810 | ||
| Median (range) | 65 (43-87) | 66 (44-82) | |
| <50 | 6 (4) | 9 (6) | |
| (50-59) | 37 (27) | 30 (21) | |
| (60-69) | 46 (34) | 56 (39) | |
| (70-79) | 36 (26) | 44 (31) | |
| 80+ | 12 (9) | 4 (3) | |
| BMI | .927 | ||
| Median (range) | 27.9 (17-47) | 28.2 (18-41) | |
| Underweight-Normal (< 25) | 30 (22) | 34 (24) | |
| Overweight (25 – 30) | 57 (42) | 61 (43) | |
| Obese (>30) | 50 (36) | 48 (34) | |
| Strata | --- | ||
| 3 – TMP/SMX - Yes, IgG > 500, Influenza vaccine - Yes | 1 (1) | 1 (1) | |
| 4 – TMP/SMX - Yes, IgG > 500, Influenza vaccine - No | |||
| 5 – TMP/SMX - No, IgG <= 500, Influenza vaccine - Yes | |||
| 6 – TMP/SMX - No, IgG <= 500, Influenza vaccine - No | |||
| 7 – TMP/SMX - No, IgG > 500, Influenza vaccine - Yes | 3 (2) | 2 (1) | |
| 8 – TMP/SMX - No, IgG > 500, Influenza vaccine - No | 94 (69) | 99 (69) | |
| Race | .623 | ||
| Hispanic | 0 (0) | 2 (1) | |
| Asian | 0 (0) | 1 (1) | |
| Black | 1 (1) | 2 (1) | |
| White | 136 (99) | 138 (97) | |
| Sex | .760 | ||
| Female | 59 (43) | 59 (41) | |
| Male | 78 (57) | 84 (59) | |
| ECOG Performance Status | .583 | ||
| 0 | 125 (91) | 133 (93) | |
| 1 | 12 (9) | 10 (7) | |