Table 4.
Summary of Adverse Events
| Cohort 1 | Cohort 2 | Cohort 3 | Pooled | |||||
|---|---|---|---|---|---|---|---|---|
| BIW | QW | P | BIW | P | BIW | P | P | |
| Adverse Event | n = 20 | n = 20 | n = 10 | n = 20 | n = 5 | n = 20 | n = 5 | n = 20 |
| Total | 12 (60.0) | 18 (90.0) | 0 (0.0) | 12 (60.0) | 0 (0.0) | 16 (80.0) | 0 (0.0) | 0 (0.0) |
| Nasopharyngitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dizziness | 1 (5.0) | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Headache | 5 (25.0) | 15 (75.0) | 0 (0.0) | 4 (20.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0 (0.0) |
| Somnolence | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Constipation | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dyspepsia | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Nausea | 9 (45.0) | 18 (90.0) | 0 (0.0) | 10 (50.0) | 0 (0.0) | 10 (50.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 4 (20.0) | 14 (70.0) | 0 (0.0) | 5 (25.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0 (0.0) |
| Pruritus | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) |
| Rash | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) |
| Arthralgia | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Chest discomfort | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Feeling abnormal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Injection site erythema | 2 (10.0) | 2 (10.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 13 (65.0) | 0 (0.0) | 0 (0.0) |
| Malaise | 2 (10.0) | 4 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Alanine aminotransferase increased | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Aspartate aminotransferase increased | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Blood pressure decreased | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Gamma‐glutamyltransferase increased | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Fractured coccyx | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
BIW, twice‐weekly 28.2‐μg injection group; P, placebo group; Pooled P, pooled placebo group; QW, once‐weekly 56.5‐μg injection group.
Data are expressed as number of subjects (%).