TABLE 1.
Patient demographics and baseline characteristics (safety population)a
| Characteristic | Value for group |
||
|---|---|---|---|
| Placebo+OTV (n = 56) | 3,600 mg MHAA4549A+OTV (n = 55) | 8,400 mg MHAA4549A+OTV (n = 47) | |
| Age (years) | 65.7 (17.5) | 56.5 (18.2) | 59.8 (17.9) |
| Age group, ≥65 (years) | 33 (59%) | 14 (26%) | 20 (43%) |
| Sex, female | 24 (43%) | 25 (46%) | 22 (47%) |
| Race | |||
| American Indian or Alaska | 1 (2%) | 0 | 1 (2%) |
| Asian | 4 (7%) | 0 | 2 (4%) |
| Black or African American | 1 (2%) | 1 (2%) | 0 |
| White | 45 (80%) | 44 (80%) | 39 (83%) |
| Multiple | 0 | 1 (2%) | 0 |
| Unknown | 5 (9%) | 9 (16%) | 5 (11%) |
| Weight (kg)b | 81 (30.8) | 83.7 (27.6) | 78.41 (17.4) |
| Oxygen requirement at randomization | |||
| Oxygen supplement (non-PPV) | 38 (68%) | 39 (71%) | 35 (75%) |
| PPV | 18 (32%) | 16 (29%) | 12 (25%) |
| Confirmed or suspected bacterial pneumonia | 32 (57%) | 24 (44%) | 23 (49%) |
| At least one medical condition | 54 (96%) | 49 (89%) | 43 (92%) |
| Influenza subtypec | |||
| H1N1 | 15/54 (28%) | 26/52 (50%) | 18/44 (41%) |
| H3N2 | 39/54 (72%) | 26/52 (50%) | 24/44 (55%) |
| Unknown | 0 | 0 | 2/44 (4%) |
a
Ages and weights are given as mean (standard deviation); other values are number (percent) of patients. Abbreviations: n, number of subjects; PPV, positive-pressure ventilation.
b
Data were not available for all safety-evaluable patients.
c
ITTI population; data are number/total (percent) for each cohort.