Table 3.
Adverse Events Following Randomization
| Placebo | Prednisone | |
|---|---|---|
| Gastrointestinal | ||
| Constipation | 0 | 1 |
| Diarrhea | 1 | 2 * |
| Flatulence | 0 | 1 |
| Nausea | 0 | 2 |
| Dysphagia | 0 | 1 |
| Neurological | ||
| Agitation | 0 | 1 * |
| Anxiety | 1 | 0 |
| Blepharospasm | 0 | 1 |
| Blurred vision | 0 | 1 |
| Headaches | 0 | 1 |
| Insomnia | 1 * | 0 |
| Eye fasciculations | 0 | 1 |
| Face fasciculations | 0 | 1 |
| Cardiovascular | ||
| Arrhythmia | 0 | 1 |
| Conduction disorder | 1 | 0 |
| Palpitations | 1 * | 0 |
| Sinus tachycardia | 1 * | 0 |
| Respiratory | ||
| Bronchitis | 0 | 1 |
| Endocrine/Metabolic | ||
| Impaired glucose tolerance | 0 | 1 * |
| Weight gain | 0 | 2 * |
| Miscellaneous | ||
| Dizziness | 1 | 0 |
| Edema | 0 | 2 |
| Hematoma | 0 | 1 |
| Myalgia/Cramping | 0 | 1 |
| Eye pain (poked in eye) | 1 | 0 |
| TOTAL | 8 | 22 |
*
Indicates that AE led to a reduction in dose of study medication.
Dose was reduced because of diarrhea in only 1 of the 2 patients in the prednisone group.