TABLE 7

Manufacturer’s Pooled Clinical Trial Data: Summary of AEs by Preferred Term Reported in ≥2% of Patients in Any Propranolol Group

Propranolola,b
1 mg/kg per day (n = 200)3 mg/kg per day (n = 235)All (N = 435)Placebob (N = 236)
n%n%n%n%
Patients with at least 1 AE17386.521290.238588.516067.8
Preferred term
 Nasopharyngitis4120.56929.411025.33715.7
 Pyrexia4422.05322.69722.3198.1
 Diarrhea2914.55322.68218.993.8
 Teething3618.03213.66815.62410.2
 Cough2814.02811.95612.9177.2
 Vomiting2412.02611.15011.5104.2
 URTI178.52811.94510.3198.1
 Bronchitis115.53012.8419.4104.2
 Peripheral coldness189.0156.4337.610.4
 Rhinitis2110.5114.7327.4114.7
 Vaccination complication168.0166.8327.420.8
 Constipation147.0156.4296.731.3
 Bronchiolitis115.5166.8276.2104.2
 Toothache63.0218.9276.273.0
 Conjunctivitis115.5156.4266.031.3
 Sleep disorder178.593.8266.031.3
 Gastroenteritis73.5187.7255.741.7
 Middle insomnia105.0146.0245.541.7
 Diaper dermatitis94.5125.1214.831.3
 Nightmare52.5156.4204.652.1
 Ear infection105.093.8194.483.4
 Decreased appetite84.093.8173.920.8
 Eczema105.052.1153.431.3
 Nasal congestion84.073.0153.431.3
 Irritability115.531.3143.231.3
 Infantile colic63.083.4143.210.4
 Rhinorrhea52.583.4133.093.8
 Flatulence84.052.1133.020.8
 Rash52.573.0122.841.7
 Somnolence105.020.9122.810.4
 Restlessness84.031.3112.531.3
 Influenza42.073.0112.520.8
 GERD42.073.0112.510.4
 Hypersomnia63.052.1112.510.4
 Abdominal pain52.552.1102.310.4
 Agitation73.531.3102.3
 Insomnia31.562.692.152.1
 Gingival pain21.073.092.141.7
 Pharyngitis52.541.792.141.7
 Viral URTI52.541.792.120.8
 Viral infection52.541.792.1
 Frequent bowel movements31.552.181.820.8
 Erythema31.552.181.810.4
 Regurgitation52.510.461.452.1
 Crying42.020.961.4
 Viral respiratory tract infection42.010.451.120.8
  • AEs are presented by frequency in the overall propranolol group. GERD, gastroesophageal reflux disease; URTI, upper respiratory tract infection.

  • a AEs in the 3-mg/kg-per-day arm included those that occurred during the uptitration period; 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.

  • b 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.