Table 2.
Adverse Events.*
| Adverse Event | FTC–TDF (N = 1251) | Placebo (N = 1248) | P Value† | ||
|---|---|---|---|---|---|
| no. of patients (%) | no. of events | no. of patients (%) | no. of events | ||
| Any adverse event | 867 (69) | 2630 | 877 (70) | 2611 | 0.50 |
| Any serious adverse event | 60 (5) | 76 | 67 (5) | 87 | 0.57 |
| Any grade 3 or 4 event | 151 (12) | 248 | 164 (13) | 285 | 0.51 |
| Grade 3 event | 110 (9) | 197 | 117 (9) | 225 | 0.65 |
| Grade 4 event | 41 (3) | 51 | 47 (4) | 60 | 0.57 |
| Elevated creatinine level | 25 (2) | 28 | 14 (1) | 15 | 0.08 |
| Headache | 56 (4) | 66 | 41 (3) | 55 | 0.10 |
| Depression | 43 (3) | 46 | 62 (5) | 63 | 0.07 |
| Nausea | 20 (2) | 22 | 9 (<1) | 10 | 0.04 |
| Unintentional weight loss (≥5%) | 27 (2) | 34 | 14 (1) | 19 | 0.04 |
| Diarrhea | 46 (4) | 49 | 56 (4) | 61 | 0.36 |
| Bone fracture | 15 (1) | 16 | 11 (<1) | 12 | 0.41 |
| Death | 1 (<1)‡ | 1 | 4 (<1) | 4 | 0.18 |
| Discontinuation of study drug | |||||
| Permanently | 25 (2) | 26 | 27 (2) | 33 | 0.82 |
| Permanently or temporarily | 79 (6) | 99 | 72 (6) | 92 | 0.49 |
*
A listing of all laboratory abnormalities and clinical adverse events of grade 2 or higher that were reported in 25 or more subjects (1%) is provided in Tables S9 and S10 in the Supplementary Appendix. FTC–TDF denotes emtricitabine and tenofovir disoproxil fumarate.
†
P values were calculated by the log-rank test.
‡
This death was due to a motorcycle accident.