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Table 5 Serious adverse events recorded during the trial

From: Gastroenteritis aggressive versus slow treatment for rehydration (GASTRO): a phase II rehydration trial for severe dehydration: WHO plan C versus slow rehydration

  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
  1. aDevelopment of hypoxia (PaO2 < 90%) with chest signs (crepitations or indrawing)
  2. 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