TABLE 1.
Full analysis set | Incomplete analysis set | |||
---|---|---|---|---|
Control (n = 11) | TRV027 (n = 10) | Control (n = 13) | TRV027 (n = 15) | |
Median (range) or (%) | Median (range) or (%) | Median (range) or (%) | Median (range) or (%) | |
Age (years) | 72 (43–79) | 70.5 (47–89) | 70.0 (43–79) | 67.0 (47–89) |
Age group | ||||
<60 | 4 (36.4) | 2 (20.0) | 6 (46.2) | 6 (40.0) |
60–69 | 0 | 2 (20.0) | 0 | 2 (13.3) |
>69 | 7 (63.6) | 6 (60.0) | 7 (53.8) | 7 (46.7) |
Gender | ||||
Male | 3 (27.3) | 4 (40.0) | 4 (30.8) | 8 (53.3) |
Female | 8 (72.7) | 6 (60.0) | 9 (69.2) | 7 (46.7) |
Ethnicity | ||||
White | 2 (18.2) | 4 (40.0) | 2 (15.4) | 5 (33.3) |
Mixed | 0 (0) | 0 (0) | 0 (0) | 1 (6.7) |
Asian | 3 (27.3) | 0 (0) | 3 (23.1) | 0 (0) |
Black | 2 (18.2) | 0 (0) | 2 (15.4) | 0 (0) |
Other | 4 (36.4) | 5 (50.0) | 5 (38.5) | 7 (46.7) |
Not reported | 0 (0) | 1 (10.0) | 1 (7.7) | 2 (13.3) |
Disease severity | ||||
Mild | 3 (27.3) | 0 (0) | 3 (23.1) | 1 (6.7) |
Moderate | 0 (0) | 1 (10.0) | 0 | 1 (6.7) |
Severe | 5 (45.4) | 1 (10.0) | 7 (53.8) | 5 (33.3) |
Critical | 3 (27.3) | 8 (80.0) | 3 (23.1) | 8 (53.3) |
Note: Data are presented for the full analysis set who received at least two infusions and had blood samples taken on Day 3 and the incomplete analysis set who were randomized but withdrawn before the primary endpoint.