Table 2a. Components of the primary mITT analysis.
16 weeks | 24 weeks | Total | |||
---|---|---|---|---|---|
Randomised | 602 | 602 | 1204 | ||
Included in analysis (assessable) | 572 | 573 | 1145 | ||
Favourable | Completed treatment and clinically well (without retreatment or otherwise unfavourable) at 72 weeks | 556 | 555 | 1111 | |
556 (97) | 555 (97) | 1111 (97) | |||
Unfavourable | Death from any cause after week 16 | 7 | 12 | 19 | |
TB events | TB recurrence | ||||
Total unfavourable (% of assessable) | 16 (3) | 18 (3) | 34 (3) |
Data presented as number of participants (%). mITT = modified intention to treat.
Both participants had treatment restarted after defaulting on treatment.