Case 1 2 3 4 5 6 7 8
SAE
Uncontrolled bronchial hyper reactivity
Hypoglycaemia without risk factor
Hypoglycaemia without risk factor
Hypoglycaemia after limited food intake
Uncontrolled bronchial hyper reactivity
Uncontrolled bronchial hyper reactivity Uncontrolled bronchial hyper reactivity
Uncontrolled bronchial hyper reactivity
medical history 0 0 0 Preterm 35 WA 0 0 Preterm 34 WA 0
age at initiation (months) 6 months 5 months 2 months 3 months 4 months 11 months 7 months 5 months
Hemangiol® dosage during SAE 3 mg/kg/day 3 mg/kg/day 3 mg/kg/day 2 mg/kg/day 3 mg/kg/day 3 mg/kg/day 3 mg/kg/day 3 mg/kg/day
Time between SAE and Hemangiol® initiation 1.5 months 7 months 5 months 4 months 8 months 4 months 5 months 11 months
Decision after SAE
Treatment suspended
Treatment suspended
Treatment suspended
Dose reduced under 2 mg/kg/day
Treatment suspended
Treatment reinitiated 3 months later
Treatment suspended
Treatment suspended
IH outcome after decision
Rebound growth Surgery
Involution
Involution
Rebound growth
Involution
Rebound growth
Involution
Involution
Causality score 2/6 5/6 3/6 2/6 2/6 5/6 2/6 4/6