Table 2. Solicited symptoms through day 28 after each dose.
|
Solicited Symptoms Through Day 28 After Each Dose, n (%)
|
||||||||
|---|---|---|---|---|---|---|---|---|
|
Dose 1
|
Dose 2
|
Dose 3
|
Overall
|
|||||
| Solicited Symptom | MEDI-559 (n=57) | Placebo (n=56) | MEDI-559 (n=46) | Placebo (n=49) | MEDI-559 (n=47) | Placebo (n=45) | MEDI-559 (n=57) | Placebo (n=56) |
| Total events, n | 543 | 497 | 393 | 345 | 284 | 254 | 1220 | 1096 |
| Subjects reporting ≥1 event (%) | 42 (73.7) | 37 (66.1) | 31 (67.4) | 34 (69.4) | 26 (55.3) | 30 (66.7) | 48 (84.2) | 51 (91.1) |
| Runny/stuffy nose (%) | 35 (61.4) | 29 (51.8) | 25 (54.3) | 28 (57.1) | 21 (44.7) | 24 (53.3) | 41 (71.9) | 49 (87.5) |
| Irritability/fussiness (%) | 27 (47.4) | 19 (33.9) | 11 (23.9) | 14 (28.6) | 16 (34.0) | 12 (26.7) | 32 (56.1) | 30 (53.6) |
| Cough (%) | 18 (31.6) | 20 (35.7) | 17 (37.0) | 12 (24.5) | 12 (25.5) | 7 (15.6) | 32 (56.1) | 29 (51.8) |
| Drowsiness (%) | 11 (19.3) | 14 (25.0) | 4 (8.7) | 8 (16.3) | 5 (10.6) | 7 (15.6) | 16 (28.1) | 21 (37.5) |
| Fever (%) | ||||||||
| 38.0°C–38.5°C | 8 (14.0) | 7 (12.5) | 6 (13.0) | 5 (10.2) | 5 (10.6) | 4 (8.9) | 18 (31.6) | 15 (26.8) |
| 38.6°C–39.5°C | 3 (5.3) | 4 (7.1) | 4 (8.7) | 6 (12.2) | 0 (0.0) | 2 (4.4) | 7 (12.3) | 10 (17.9) |
| 39.6°C–40.5°C | 1 (1.8) | 2 (3.6) | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (3.5) | 2 (3.6) |
| >40.5°C | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |