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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.