Table 3.
Safety outcomes
| Cases/person-weeks | Observed number of events | Effect (95% CI) | |
|---|---|---|---|
| Reported side-effects (aggregate score) | |||
| Reference group | 220/1974 | 111 per 1000 person-weeks | ·· |
| 60 mg screen-and-treat approach | 261/1906 | 135 per 1000 person-weeks | 1·2 (0·8 to 1·8) |
| 30 mg screen-and-treat approach | 154/2009 | 78 per 1000 person-weeks | 0·7 (0·5 to 1·0) |
| Adverse events | |||
| Reference group | 167/1902 | 89 per 1000 person-weeks | ·· |
| 60 mg screen-and-treat approach | 149/1861 | 82 per 1000 person-weeks | –7·4 (–26·0 to 11·1) |
| 30 mg screen-and-treat approach | 175/1945 | 89 per 1000 person-weeks | 1·6 (–17·2 to 20·3) |
| Serious adverse events (DSMB notified) | |||
| Reference group | 9/1904 | 29 per 10 000 person-weeks | ·· |
| 60 mg screen-and-treat approach | 14/1861 | 47 per 10 000 person-weeks | 18·7 (–12·3 to 49·8) |
| 30 mg screen-and-treat approach | 6/1945 | 18 per 10 000 person-weeks | –10·2 (–34·0 to 13·6) |
Individual complaints and adverse events are listed in the appendix (pp 20–22). Estimates of adverse events and serious adverse events were based on a negative binomial model, accounting for differences in exposure. The effect and 95% CI are the respective exponentiated relative changes in observed counts and their CIs. DSMB=data safety monitoring board.