Table 5.
Font trial: adverse events
| Symptom category | Adalmumab (N = 7) | Galactose (N = 7) | Standard Therapy (N = 7) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| N PTs with events | % of Rand PTs | N events | N PTs with events | % of Rand PTs | N events | N PTs with events | % of Rand PTs | N events | |
| Allergy | 1 | 14.3 | 1 | 2 | 28.6 | 2 | 1 | 14.3 | 1 |
| Anorexia | 2 | 28.6 | 4 | 1 | 14.3 | 1 | 0 | 0 | 0 |
| CV | 0 | 0 | 0 | 1 | 14.3 | 1 | 0 | 0 | 0 |
| Cataract | 0 | 0 | 0 | 1 | 14.3 | 1 | 0 | 0 | 0 |
| Cosmetic | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 14.3 | 2 |
| Cough | 3 | 42.9 | 3 | 2 | 28.6 | 3 | 1 | 14.3 | 1 |
| Dehydration | 2 | 28.6 | 5 | 1 | 14.3 | 5 | 0 | 0 | 0 |
| Dizziness | 0 | 0 | 0 | 4 | 57.1 | 6 | 1 | 14.3 | 1 |
| Edema | 6 | 85.7 | 100 | 5 | 71.4 | 57 | 6 | 85.7 | 23 |
| Fatigue | 5 | 71.4 | 8 | 2 | 28.6 | 5 | 1 | 14.3 | 1 |
| GI | 4 | 57.1 | 7 | 2 | 28.6 | 6 | 1 | 14.3 | 2 |
| Headache | 4 | 57.1 | 6 | 4 | 57.1 | 8 | 1 | 14.3 | 1 |
| Hypotension | 1 | 14.3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Infection | 5 | 71.4 | 49 | 5 | 71.4 | 20 | 4 | 57.1 | 10 |
| Miscellaneous | 4 | 57.1 | 13 | 4 | 57.1 | 7 | 4 | 57.1 | 13 |
| Musculoskeletal | 3 | 42.9 | 8 | 1 | 14.3 | 2 | 4 | 57.1 | 8 |
| Nausea | 2 | 28.6 | 2 | 2 | 28.6 | 12 | 0 | 0 | 0 |
| Pain | 2 | 28.6 | 9 | 4 | 57.1 | 14 | 3 | 42.9 | 3 |
| Renal | 2 | 28.6 | 8 | 1 | 14.3 | 4 | 1 | 14.3 | 1 |
| Respiratory | 1 | 14.3 | 2 | 2 | 28.6 | 2 | 2 | 28.6 | 2 |
| Skin | 2 | 28.6 | 3 | 3 | 42.9 | 14 | 3 | 42.9 | 8 |
| Vomiting | 2 | 28.6 | 5 | 2 | 28.6 | 5 | 0 | 0 | 0 |
Number of Participants with Adverse Events Reported Overall After Consent