Table 4 Serious adverse events by treatment group (safety population)
Serious adverse event, n (%) of subjects | MEDI-528 | ||||
|---|---|---|---|---|---|
Placebo | 30 mg | 100 mg | 300 mg | Combined | |
(n = 82) | (n = 81) | (n = 83) | (n = 81) | (n = 245) | |
Asthma | 0 (0.0) | 6 (7.4) | 1 (1.2) | 2 (2.5) | 9 (3.7) |
Pneumonia | 0 (0.0) | 3 (3.7) | 0 (0.0) | 0 (0.0) | 3 (1.2) |
Food allergy | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Bronchitis | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Lobar pneumonia | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 1 (0.4) |
Limb traumatic amputation | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Thoracic vertebral fracture | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 1 (0.4) |
Muscle spasms | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 1 (0.4) |
Uterine leiomyoma | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 1 (0.4) |
Complicated migraine | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Ischemic stroke | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
Vaginal hemorrhage | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 1 (0.4) |
Pancreatitis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Cholelithiasis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hydrocholecystis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Appendicitis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Nephrolithiasis | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |