Table 5.
Adverse events
| Pt ID | Adverse event | Study Week of onset |
severity | Possibility of being caused by drug |
History of similar Event |
Action taken | Resolution | Cause of Study Exit? |
|---|---|---|---|---|---|---|---|---|
| 3 | Edema | 2 | Severe | No | Yes | Albumin/lasix Infusion |
Resolved | No |
| 5 | Fever/Mylagias | 4 | Moderate | No | Yes | Oral Antibiotic | Resolved | No |
| 5 | Intermittent foot pain |
2 | Moderate | No | No | Oral Antibiotic | Resolved | No |
| 6 | Injection Site Reaction |
19 | Mild | Probable | No | None | Resolved | No |
| 8 | Ascites; Pleural effusion; Peritonitis |
4 | Moderate | No | No | IV and oral antibiotics |
Resolved | No |
| 9 | Edema | 10 | Moderate | No | Yes | Albumin/lasix infusion |
Resolved | N0 |
| 9 | Avascular necrosis of the femoral heads |
5 | Severe | No | No | Bedrest, to be followed by surgery |
No, awaiting surgery | Yes; Early Steady State pharmacoki netics |
| 9 | Fever/Cough | 7 | Moderate | Unlikely | Yes | IV antibiotics | Resolved. | No |
| 10 | Fever/Nausea | 15 | Moderate | No | Yes | None | Resolved | No |
Patients 1, 2, 4, and 7 did not have any adverse events.