Outcome measures
The data collection included the population and IH characteristics and
the indication of treatment during the initial consultation. Patient
follow-up included treatment initiation until the end of treatment.
We collected all data from patient monitoring (cardiac examination,
echocardiogram, ECG, cardiac monitoring) before, during (at each
titration stage for both conventional and rapid protocols), and after
Hemangiol® initiation.
Parents of children under Hemangiol® were asked to call the paediatric
cardiology 24-hour hotline for any clinical symptom. Therefore, we
recorded all adverse events (AEs), defined as any undesirable experience
possibly associated with the use of Hemangiol® from drug initiation and
throughout the follow-up. Serious adverse events (SAEs) were defined as
life-threatening events or adverse events leading to death,
hospitalization, disability or permanent damage, intervention to prevent
permanent impairment, or any important medical event as defined by the
drug agencies. SAEs were reported to pharmacovigilance and causality was
established using the standard method derived from Bégaud et al19. This algorithm is based on an intrinsic score
including chronological and semiological criteria ranging from 0 to 6
(from absence to strong relationship between drug and the occurrence of
adverse event; scores ≥2 indicating possible relation to treatment) and
an extrinsic score based on bibliography20.