TABLE 4.
Grade III or IV adverse events (severe or life threatening) possibly or probably related to the study drug
| Group | No. of subjects who received:
|
Total no. of subjects | ||||
|---|---|---|---|---|---|---|
| Placebo | Tenofovir DF dose (mg) of:
|
|||||
| 75 | 150 | 300 | 600 | |||
| All subjects | 11 | 12 | 8 | 8 | 10 | 49 |
| Subjects with an event | 1 | 1 | 0 | 4 | 0 | 6 |
| Subjects with peripheral neuropathy | 1 | 0 | 0 | 1 | 0 | 2 |
| Subjects with CK elevation | 1 | 1 | 0 | 4 | 0 | 6 |
| Subjects with AST and/or ALT elevation | 0 | 1 | 0 | 1 | 0 | 2 |