Table 5 Safety of IPTsc during intervention period
| Author (year) | Study site | Drug regime | No of children | Adverse events | Observation |
|---|---|---|---|---|---|
| Dicko [23] | Kambila | SP (bimonthly) | 61 | No severe adverse event | No data available |
| Control | 90 | ||||
| Clarke [24] | Bondo | SP + AQ (four-monthly) | 2604 |
19 (0.79 %) severe adverse events (problems of balance, dizziness, feeling faint, nausea or vomiting) 6 (0.23 %) adverse events graded as moderate 49 (1.9 %) mild events (nausea, headache, prurititis) | Mild events were more frequent among children receiving active drugs than among controls |
| Placebo | 2302 |
4 (0.17 %) severe adverse events (problems of balance, dizziness, feeling faint, nausea or vomiting and one severe skin reaction) 7 (0.30 %) moderate adverse events 33 (1.4 %) mild events (nausea, headache, prurititis) | |||
| Barger [25] | Kollé | SP + AS | 96 | Most adverse events: headache, abdominal pain and respiratory symptoms. | – |
| AQ + AS | 100 | ||||
| Placebo | 98 | ||||
| Nankabirwa [26] | Tororo | SP | 184 |
No severe adverse events. Only mild (92 %) and moderate (8 %), with no difference between treatment groups | – |
| SP + AQ | 197 | ||||
| DP | 196 | ||||
| Placebo | 192 | ||||
| Nankabirwa [27] | Tororo | DP (monthly) | 244 | 6 (2.5 %) severe adverse events | Mild events were more frequent in the placebo group than the intervention arms |
| DP (three to five monthly) | 248 | 1 (0.40 %) death (due to acute lymphoblastic leukaemia); 5 (2 %) severe adverse events | |||
| Placebo | 248 | 3 (1.2 %) severe adverse events |
