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Table 2 Primary and secondary endpoints observed in the different treatment groups in both studiesa

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

  Panel A: Clinical Trial Panel B: Observational Cohort
Placebo (N = 12) MgSO4 (N = 14) Estimated effect (95% CI) p-value Control (N = 12) MgSO4 (N = 33) Estimated effect (95% CI) p-value
Primary endpointb 6 (50%) 6 (43%) 0.84 (0.37, 1.92) 0.682 2 (17%) 1 (3%) 0.16 (0.01, 1.79) 0.132
Requirement for ventilation 1 (8%) 1 (7%)   2 (17%) 1 (3%) 0.16 (0.01, 1.79) 0.132
Requirement for milrinone 6 (50%) 6 (43%) 0.80 (0.25, 2.55) 0.706  
Time to start of milrinonec 1.6 (0.6, 19.5) 2.0 (1.2, 3.8)    
Length of hospitalizationc 5 (5, 6) 5 (5, 6) 0.12 (−1.55, 1.79) 0.889 9 (8, 13) 9 (7, 10) −1.65 (−3.79, 0.49) 0.117
  1. The estimated effect for the primary endpoint and for requirement for ventilation is the relative risk, while for length of hospitalization it is the mean difference, and for requirement for milrinone it is the hazard ratio
  2. Results are based on log-binomial regression (primary endpoint, requirement for ventilation), linear regression (length of hospitalization), Cox regression (requirement for milrinone). For those patients who never received milrinone the nominal start time was fixed at 72 h. All analyses were adjusted for age and illness day (except for Cox regression analysis which was adjusted for illness day and systolic blood pressure at baseline)
  3. aPanel A for the clinical trial and Panel B for the observational cohort
  4. bFor the clinical trial the primary endpoint was a composite outcome of death or shock or requirement for ventilation or need for milrinone, while for the observational cohort it comprised death or shock or requirement for ventilation (since all study participants were already on milrinone)
  5. cLength of hospitalization and time to start of milrinone are summarized in terms of median (range) values. Length of hospitalization is the number of days from study enrolment to hospital discharge. Time to start of milrinone is the number of hours from initiation of study drug to addition of milrinone, and is only described for patients who received milrinone