Table 4.
Serious adverse events
| Age (years) | Sex | Maximum severity | Related to DP* | Event outcome | |
|---|---|---|---|---|---|
| Death after motor vehicle accident | 8 | Girl | Life threatening | No | Death |
| Death after tetanus infection | 7 | Boy | Life threatening | No | Death |
| Allergic dermatitis (generalised papular rash) | 10 | Boy | Severe | Possibly | Resolved, without sequelae |
| Weakness and loss of consciousness after severe abdominal pain | 12 | Girl | Severe | Possibly | Resolved, without sequelae |
| Acute gastritis and upper respiratory tract infection | 8 | Girl | Severe | Unlikely | Resolved, without sequelae |
| Acute gastritis with moderate dehydration | 8 | Girl | Severe | Unlikely | Resolved, without sequelae |
| Severe body weakness†‡ | 9, 11, 12, and 13 | All girls | All severe | All unlikely | All resolved, without sequelae |
| Malaria with upper respiratory tract infection | 8 | Boy | Severe | Unlikely | Resolved, without sequelae |
| Malaria with gastroenteritis | 12 | Boy | Severe | Unlikely | Resolved, without sequelae |
| Multiple fractures after road traffic accident | 8 | Girl | Severe | No | Resolved, without sequelae |
| Malaria | 7 | Boy | Severe | No | Resolved, without sequelae |
| Malaria, upper respiratory tract infection, and oral candidiasis | 7 | Boy | Severe | No | Resolved, without sequelae |
| Malaria and suspected bacteraemia | 7 | Girl | Severe | No | Resolved, without sequelae |
| Epigastric pain attributed to peptic ulcer disease‡ | 13 | Girl | Moderate | Unlikely | Resolved, without sequelae |
DP=dihydroartemisinin-piperaquine.
*
Study staff assessed serious adverse events to determine the suspected relationship to DP.
†
Four study participants from the same school had severe body weakness on the same day after mass administration of azithromycin for trachoma.
‡
Two serious adverse events were seen in one participant.