Table 2. Primary Outcome Classification According to Treatment Group for the Per-Protocol and Modified Intention-to-Treat Analyses*.
| Status and Outcome | Control Regimen | 4-Month Regimen | 6-Month Regimen | Total |
|---|---|---|---|---|
| Per-protocol analysis — no. | 163 | 165 | 186 | 514 |
| Favorable — no. (%) | 155 (95.1) | 135 (81.8) | 180 (96.8) | 470 (91.4) |
| Unfavorable | ||||
| Failure (culture confirmed) — no. | 2 | 2 | 0 | 4 |
| Death during treatment — no. | 1 | 0 | 1 | 2 |
| Relapse (culture confirmed) — no. | 4 | 19 | 4 | 27 |
| Relapse (limited bacteriology) — no. | 1 | 7 | 1 | 9 |
| Culture positive when last seen — no. | 0 | 2 | 0 | 2 |
| Total — no. (%) | 8 (4.9) | 30 (18.2) | 6 (3.2) | 44 (8.6) |
| Difference from control in unfavorable rate (adjusted for study center) | 13.6 | −1.8 | ||
| 90% CI | 8.1 to 19.1 | −6.1 to 2.4 | ||
| 95% CI | 7.0 to 20.2 | −6.9 to 3.3 | ||
| Modified intention-to-treat analysis — no. | 188 | 193 | 212 | 593 |
| Favorable — no. (%) | 161 (85.6) | 141 (73.1) | 183 (86.3) | 485 (81.8) |
| Unfavorable | ||||
| During treatment — no. | ||||
| Failure (culture confirmed) | 2 | 2 | 0 | 4 |
| Death | 1 | 0 | 1 | 2 |
| Change in treatment due to adverse event | 1 | 2 | 2 | 5 |
| Lost to follow-up | 5 | 6 | 8 | 19 |
| Inadequate treatment | 2 | 1 | 3 | 6 |
| Other treatment change† | 10 | 11 | 10 | 31 |
| After treatment — no. | ||||
| Relapse | ||||
| Culture confirmation | 4 | 19 | 4 | 27 |
| Limited bacteriologic confirmation‡ | 2 | 8 | 1 | 11 |
| Death due to tuberculosis | 0 | 1 | 0 | 1 |
| Culture positive when last seen | 0 | 2 | 0 | 2 |
| Total — no. (%) | 27 (14.4) | 52 (26.9) | 29 (13.7) | 108 (18.2) |
| Difference from control in unfavorable rate (adjusted for study center) | 13.1 | 0.4 | ||
| 90% CI | (6.8 to 19.4) | (−4.7 to 5.6) | ||
| 95% CI | (5.6 to 20.6) | (−5.7 to 6.6) |
*
CI denotes confidence interval.
†
Reasons for other treatment changes included poor adherence, withdrawal due to pregnancy after a positive culture, withdrawal of consent, and a move away from treatment center.
‡
Limited bacteriologic confirmation indicates that retreatment for relapse was initiated without confirmation on two positive cultures within 4 months after completion of treatment when no negative culture was obtained during the intervening 4 months.