TABLE 6

Summary of Treatment-Emergent AEs Across Selected Data Sources

Manufacturer’s Pooled Dataa
PropranololPropranolol
1 mg/kg per day (n = 200)3 mg/kg per day (n = 235)All (N = 435)Placebo (N = 236)CUPb (N = 1661)Literature Data (N = 3766)
n%n%n%n%n%n%
Patients with at least 1 AE17386.521290.238588.516067.81619.7578c15.3
Patients with at least 1 related AEd8241.08435.716638.23615.3
Patients with at least 1 AE leading to definitive study drug discontinuation42.073.0112.5104.2432.6892.4
Patients with at least 1 serious AEe73.5146.0214.862.5402.4
Deaths30.220.1
  • a Manufacturer’s pooled clinical trial data: AEs in the 3-mg/kg-per-day arm included those that occurred during the uptitration period; “related” indicates events with a relationship to the study drug other than “Not Suspected”; patients in study 301 who received 2 mg/kg per day of propranolol were analyzed with the 3-mg/kg-per-day group for data described by dose and in the “all propranolol” column describing all patients treated with propranolol whatever the dose. All AEs presented are treatment-emergent AEs. Data are presented by dose of propranolol or placebo (whatever the assigned regimen) and for all patients treated with propranolol whatever the dose. Therefore, for those patients assigned to one of the two 3-mo propranolol regimens (followed by 3 mo taking placebo), data are presented within both the propranolol and placebo groups according to the period during which the event occurred.

  • b CUP data were reported by case; 1 patient could present ≥1 case. For the purpose of this review, the worst-case scenario has been taken (ie, 1 case = 1 patient).

  • c A total of 578 patients reported to have experienced at least 1 AE and 1399 patients reported to have experienced individual AEs by preferred term (see Supplemental Appendices 4 and 5).

  • d Not determined for CUP or literature data.

  • e Not determined for literature data.