Table 3.
Safety Analysis.*
| Adverse Event | Control Group (N = 639) | Isoniazid Group (N = 655) | Ethambutol Group (N = 636) | All Patients (N = 1930) |
|---|---|---|---|---|
| number of patients (percent) | ||||
| During treatment phase or follow-up | ||||
|
| ||||
| Any | 123 (19) | 127 (19) | 111 (17) | 361 (19) |
|
| ||||
| Grade 3 only | 83 (13) | 90 (14) | 82 (13) | 255 (13) |
|
| ||||
| Grade 4 | 40 (6) | 37 (6) | 29 (5) | 106 (5) |
|
| ||||
| Serious adverse event | 59 (9) | 62 (9) | 52 (8) | 173 (9) |
|
| ||||
| Death | ||||
|
| ||||
| Any | 16 (3) | 15 (2) | 12 (2) | 43 (2) |
|
| ||||
| Tuberculosis-related | 11 (2) | 10 (2) | 9 (1) | 30 (2) |
|
| ||||
| During treatment phase only | ||||
|
| ||||
| Any | 111 (17) | 105 (16) | 99 (16) | 315 (16) |
|
| ||||
| Grade 3 only | 76 (12) | 71 (11) | 73 (11) | 220 (11) |
|
| ||||
| Grade 4 | 35 (5) | 34 (5) | 26 (4) | 95 (5) |
|
| ||||
| Serious adverse event | 46 (7) | 40 (6) | 35 (6) | 121 (6) |
|
| ||||
| Death | ||||
|
| ||||
| Any | 5 (1) | 6 (1) | 5 (1) | 16 (1) |
|
| ||||
| Tuberculosis-related | 4 (1) | 6 (1) | 5 (1) | 15 (1) |
*
Listed are all patients who had at least one grade 3 or 4 adverse event. The safety population includes all patients who underwent randomization and who received at least one dose of a study drug. One patient who underwent randomization but did not receive a study drug was excluded from the safety analysis. A detailed list of serious adverse events is provided in Table S10 in the Supplementary Appendix.