TABLE 3.
Summary of frequency of adverse events according to CTCAE criteriaa
| AE grade | No. of AEs for subjects receiving: |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| All subjects (n = 150) | 600 mg rifampin (n = 50) |
900 mg rifampin (n = 50) |
1,200 mg rifampin (n = 50) |
|||||||
| All | Related | Unrelated | All | Related | Unrelated | All | Related | Unrelated | ||
| Grade 1 (mild AEs) | 821 | 273 | 120 | 153 | 239 | 110 | 129 | 309 | 105 | 204 |
| Grade 2 (moderate AEs) | 160 | 48 | 16 | 32 | 48 | 10 | 38 | 64 | 9 | 55 |
| Grade 3 (severe AEs) | 20 | 6 | 5 | 1 | 5 | 1 | 4 | 9 | 5 | 4 |
| Grade 4 (life-threatening AEs) | 0 | 0 | 0 | 0 | ||||||
| Grade 5 (death related to AE) | 3 | 1 | 1 | 1 | 1 | 1 | 1 | |||
a
The CTCAE criteria are described elsewhere (24). AE, adverse event; related, the AE is considered associated with the use of the investigational product if the attribution is possible, probable, or very likely.