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Table 4 Adverse events observed in the two treatment arms in the clinical trial

From: Assessing the efficacy and safety of magnesium sulfate for management of autonomic nervous system dysregulation in Vietnamese children with severe hand foot and mouth disease

  Number of patients with event
Placebo (n = 12) MgSO4 (n = 14)
Clinical events
 All adverse eventsa 21 / 10 (83) 22 / 10 (71)
  Fever 6 7
  Diminished deep tendon reflexes 2 3
  Coma / lethargy / irritability 2 1
  Respiratory problems 3 4
  Reduced urine output (< 1 ml/kg/hr for 4 h) 4 5
  Otherb,c 4 2
 Serious adverse events (Grades 3 and 4)a 3 / 2 (17) 3 / 3 (21)
  Coma 1 0
  Respiratory distress 2 3
Laboratory events
 All adverse eventsa 46 / 12 (100) 51 / 13 (93)
   Respiratory Acidosis 0 3
  Respiratory Alkalosis 8 6
  Abnormal CK-MB 7 9
  Abnormal Creatinine 2 2
  Abnormal Hb 4 4
  Hyperkalemia 2 0
  Hypokalemia 5 2
  Hyponatremia 9 9
  Abnormal Troponin I 5 5
 Serious adverse events (Grades 3 and 4)a 16 / 8 (67) 21 / 10 (71)
  Respiratory Acidosis 0 1
  Respiratory Alkalosisd 3 6
  Abnormal CK-MB 1 0
  Abnormal Hb 1 0
  Hypokalemia 1 1
  Hyponatremiae 5 7
  Abnormal Troponin I 5 4
  1. Adverse events were graded using the CTCAE Version 4.03 system, modified for children
  2. aNumbers are total events / events grouped by patient (% of patients in the group with any events)
  3. bPlacebo group: 2 with generalised erythema, 1 diarrhoea, 1 measles
  4. cMgSO4 group: 1 case each of vomiting and myoclonic jerks
  5. dIn all cases respiratory alkalosis occurred in spontaneously breathing patients
  6. eSevere hyponatremia developed in patients not receiving concurrent intravenous fluids