Table 2.
Risk of harms in each group
| Intervention group | Control group | Risk ratio (95% CI) | Risk difference (95% CI) | p value | ||
|---|---|---|---|---|---|---|
| Adverse events* | 45/1447 (3%) | 24/1265 (2%) | 1·63 (1·00 to 2·67) | 1·21 (0·04 to 2·38) | 0·060† | |
| Adverse events in child cohort only‡ | 18/327 (6%) | 14/263 (5%) | 1·03 (0·52 to 2·04) | 0·18 (−3·49 to 3·85) | 0·93† | |
| Classification | ||||||
| Adverse reaction | 5/45 (11%) | 3/24 (13%) | .. | .. | 1·00§ | |
| Serious adverse event | 19/45 (42%) | 10/24 (42%) | .. | .. | 0·83† | |
| Serious adverse reaction | 0/45 | 0/24 | .. | .. | .. | |
| Suspected unexpected serious adverse reaction | 0/45 | 0/24 | .. | .. | .. | |
| Intensity grade | ||||||
| 1 (mild) | 6/45 (13%) | 6/24 (25%) | .. | .. | 0·38† | |
| 2 (moderate) | 18/45 (40%) | 11/24 (46%) | .. | .. | 0·83† | |
| 3 (severe) | 6/45 (13%) | 2/24 (8%) | .. | .. | 0·70§ | |
| 4 (life-threatening) | 1/45 (2%) | 0/24 | .. | .. | 1·00§ | |
| 5 (death) | 13/45 (29%) | 5/24 (21%) | .. | .. | 0·66† | |
| Not classified | 1/45 (2%) | 0/24 | .. | .. | .. | |
| Outcome‖ | ||||||
| Standard | 12/45 (27%) | 9/24 (38%) | .. | .. | 0·51† | |
| Hospitalisation | 5/45 (11%) | 5/24 (21%) | .. | .. | 0·46† | |
| Death | 15/45 (33%) | 5/24 (21%) | .. | .. | 0·42† | |
| None or not classified | 13/45 (29%) | 5/24 (21%) | .. | .. | .. | |
Data are n/N (%) unless stated otherwise.
69 total adverse events in 65 participants (23 in the control group and 42 in the intervention group) were recorded (four participants had a second adverse event).
Yates' corrected p value for χ2.
Excludes uncomplicated malaria episodes in children in the active case detection cohort (the primary outcome), but includes serious or complicated malaria episodes in those children.
p value from Fisher's exact test.
Standard indicates adverse events that were observed until they self-resolved, were treated according to WHO guidelines if they were possibly intervention-related, or were referred to the district health authorities; none indicates events that were already resolved at the time of reporting to study clinicians; three events were not classified by outcome.