Table 4.
Treatment-emergent adverse events experienced by at least one galcanezumab-treated subject after multiple-dose administration by MedDRA preferred term.
| MedDRA preferred term | Galcanezumab 150 mg (n = 7) | Placebo (n = 2) |
|---|---|---|
| Subjects with at least 1 TEAE | 7 (100) | 2 (100) |
| Nasopharyngitis | 2 (29) | 2 (100) |
| Injection site pain | 2 (29) | 0 (0) |
| Hematuria | 1 (14) | 1 (50) |
| Oral herpes | 1 (14) | 1 (50) |
| Arthropod bite | 1 (14) | 0 (0) |
| Chest discomfort | 1 (14) | 0 (0) |
| Dermatitis contact | 1 (14) | 0 (0) |
| Flatulence | 1 (14) | 0 (0) |
| Gastroenteritis | 1 (14) | 0 (0) |
| Influenza like illness | 1 (14) | 0 (0) |
| Injection site erythema | 1 (14) | 0 (0) |
| Mouth ulceration | 1 (14) | 0 (0) |
| Pain in extremity | 1 (14) | 0 (0) |
| Pharyngitis | 1 (14) | 0 (0) |
| Productive cough | 1 (14) | 0 (0) |
| Rash | 1 (14) | 0 (0) |
| Tension headache | 1 (14) | 0 (0) |
| Toothache | 1 (14) | 0 (0) |
| Vessel puncture site hematoma | 1 (14) | 0 (0) |
Data are presented as No. (%) of patients experiencing the TEAE. The following TEAEs occurred in placebo in only 1 (50%) subject each: bronchitis, headache, injection site hemorrhage, and nasal congestion. MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.