Table 5.
Serious adverse events recorded during the trial
| WHO plan C n = 61 |
GASTRO slow n = 61 |
|
|---|---|---|
| Number of SAEs | 3 (4.9%) | 3 (4.9%) |
| Outcome of SAE | ||
| Resolved | 1 | 1 |
| Died | 2 (3.3%) | 2 (3.3%) |
| Relationship to study fluid | ||
| Unlikely to be related | 2 | 3 |
| Probably related | 1 | 0 |
| Nature of event | ||
| Pulmonary oedemaa | 0 | 1 |
| Cardiovascular collapseb | 2 | 1 |
| Other: | ||
| Status Epilepticus (child with severe malarial anaemia) | 1 | 0 |
| Convulsions | 0 | 1 |
aDevelopment of hypoxia (PaO2 < 90%) with chest signs (crepitations or indrawing)
bSigns of shock at the point of demise: severe tachycardia or bradycardia plus one of prolonged CRT > 2 s, cold peripheries or low systolic blood pressure