Table 4.
Adverse Events During the 12 Month Trial
| Active N = 69 | Placebo N = 69 | |
|---|---|---|
| Hospitalizations | 28 | 27 |
| Crohn Disease flare | 20 in 13 participants | 25 in 15 participants |
| Migraine | 4 in 1 participant | 0 |
| Myositis | 1 | 0 |
| Pneumonia | 1 | 0 |
| Viral illness | 0 | 1 |
| Appendectomy | 1 | 0 |
| Pyelonephritis | 0 | 1 |
| Cellulitis | 1 | 0 |
| Reported Symptoms at Study Visits | 21 | 18 |
| Abdominal pain | 5 | 0 |
| Stool changes | 5 | 0 |
| Nausea, motion sickness or dizziness | 2 | 2 |
| Vision change | 0 | 0 |
| Anxiety | 0 | 1 |
| Back pain | 3 | 2 |
| Lower extremity pain | 3 | 6 |
| Other joint pain (not lower extremity) | 0 | 3 |
| Headache | 2 | 4 |
| Urinary urgency | 1 | 0 |