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Table 5 Safety measures

From: The effect of Bosentan on exercise capacity in Fontan patients; rationale and design for the TEMPO study

Observation Action
Systolic blood pressure < 80 mmHg Exclusion
Hemoglobin < 6.5 mmol/l Exclusion
> 10% decrease in oxygen saturation Exclusion
> 10% decrease in packed cell volume Exclusion
> 10% decrease in thrombocytes Exclusion
Two times increase in bilirubin* Exclusion
Liver transaminases 3–5 times reference limit Continue in study at half dose of medication
Liver transaminases >5 times reference limit Exclusion
  1. *In patients with bilirubin at baseline within the reference limits an increase to 2 x upper reference limit leads to exclusion; if bilirubin is already over reference limit at baseline, a bilirubin increase to 2 x the baseline value leads to exclusion.