Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation (CLARINET LT)

• Number of Participants With Bleeding Events [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: Yes ]

  All bleeding events experienced during the study period were collected as for any Adverse Event.

  The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted.

  
  
• Number of Participants According to Bleeding Type/Etiology [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: Yes ]
  For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.
  
  

• Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths [ Time Frame: Up to a maximum of 6 months ] [ Designated as safety issue: No ]

  Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.

  Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first).

  
  

Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.