Table 4.
Font trial: serious adverse events
| Event | Adalimumab (N = 7) | Galactose (N = 7) | Standard Therapy (N = 7) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| N PTs with events | % Rand PTs | N Events | N PTs with events | % Rand PTs | N events | N PTs with events | % Rand PTs | N events | |
| Fatal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Immediate Life Threatening | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Required Hospitalization | 3 | 42.9 | 32 | 1 | 14.3 | 9 | 1 | 14.3 | 1 |
| Prolonged Existing Hospitalization | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Persistent or Significant Disability/Incapacity | 0 | 0 | 0 | 1 | 14.3 | 1 | 0 | 0 | 0 |
| Congenital Anomaly / Birth Defect | 1 | 14.3 | 1 | 1 | 14.3 | 1 | 0 | 0 | 0 |
| Causes Cancer | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overdose of Study Medication | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
This Table summarizes the serious adverse events that occurred throughout the study period from screening through to the end of the 6 month observation period after the completion of the experimental therapy