TABLE 1.
Demographic data in the phase II and III studies full analysis set (FAS)
| Item | Statistics | Phase II | Phase III | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| MA group | HA group | MB group | HB group | Total | MA group | ||||||
| Number of analyzed subjects | 62 | 61 | 63 | 60 | 246 | 364 | |||||
| Age (year) | Mean | 39.5 | 39.3 | 38.9 | 38.7 | 39.1 | 37.8 | ||||
| Standard deviation | 12.9 | 10.4 | 10.9 | 10.4 | 11.1 | 11.2 | |||||
| Minimum | 20 | 22 | 21 | 20 | 20 | 20 | |||||
| Median | 36.0 | 39.0 | 38.0 | 37.0 | 37.0 | 37.5 | |||||
| Maximum | 64 | 63 | 62 | 64 | 64 | 64 | |||||
| Number of subjects （Incidence %） | |||||||||||
| Age | 41 y and over | 37 (59.7) | 35(57.4) | 36 (57.1) | 35 (58.3) | 143 (58.1) | 222 (61.0) | ||||
| Less than 40 y | 25 (40.3) | 26 (42.6) | 27 (42.9) | 25 (41.7) | 103 (41.9) | 142 (39.0) | |||||
| Sex | Male | 27 (43.5) | 28 (45.9) | 29 (46.0) | 28 (46.7) | 112 (45.5) | 179 (49.2) | ||||
| Female | 35 (56.5) | 33 (54.1) | 34 (54.0) | 32 (53.3) | 134 (54.5) | 185 (50.8) | |||||
| Ethnicity | Japanese | 62 (100.0) | 61 (100.0) | 63 (100.0) | 60 (100.0) | 246 (100.0) | 364 (100.0) | ||||
| Other | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0(0.0) | |||||
| Medical history | No | 58 (93.5) | 56 (91.8) | 57 (90.5) | 55 (91.7) | 226 (91.9) | 342 (94.0) | ||||
| Yes | 4 (6.5) | 5 (8.2) | 6 (9.5) | 5 (8.3) | 20 (8.1) | 22(6.0) | |||||
| Underlying disease | No | 48 (77.4) | 50 (82.0) | 54 (85.7) | 52 (86.7) | 204(82.9) | 285 (78.3) | ||||
| Yes | 14 (22.6) | 11 (18.0) | 9 (14.3) | 8 (13.3) | 42 (17.1) | 79 (21.7) | |||||
| Allergy | No | 56 (90.3) | 51 (83.6) | 57 (90.5) | 54 (90.0) | 218 (88.6) | 289(79.4) | ||||
| Yes | 6 (9.7) | 10 (16.4) | 6 (9.5) | 6 (10.0) | 28 (11.4) | 75 (20.6) | |||||
MA group; 3.75 μg HA + AS03. HA group; 7.5 μg HA + AS03. MB group; 3.75 μg HA + 1/2 AS03. HB group; 7.5 μg HA + 1/2 AS03.