Triaxis ® SmPC Triaxis®PASS
% % (CI)
Metabolism and Nutrition Disorders    
Anorexia (decreased appetite)[1] ≥10% 7.95% (5.70-10.21)
Nervous System Disorders    
Headachea ≥10% 5.60% (3.69-7.52)
Gastrointestinal Disorders    
Diarrheaa ≥10% 0.36% (0.00-0.08)
Nauseaa ≥1% and <10% 1.27% (3.34-2.20)
Vomitinga ≥ 1% and <10% 0.90% (0.11-1.69)
Skin and Subcutaneous System Disorders    
Rasha ≥1% and <10% 1.63% (0.57-2.68)
Musculoskeletal and Connective Tissue Disorders    
Arthralgia/joint swellinga ≥1% and <10% 2.71% (1.37-4.07)
Generalized aching or muscular weaknessa ≥1% and <10% 3.98% (2.35-5.61)
General Disorders and Administrative Site Conditions    
Asthenia/Fatiguea (tiredness) ≥10% 13.74% (10.87-16.61)
Chillsa ≥1% and <10% 2.89% (1.50-4.29)
Pyrexia (fever ≥38°C)a ≥1% and <10% 4.52% (2.79-6.25)
Axillary adenopathya ≥1% and <10% 0.54% (0.00-1.15)
Injection-site paina ≥10% 67.27% (63.36-71.18)
Injection-site swellinga ≥10% 35.44% (31.46-39.43)
Injection-site erythemaa ≥10% 38.88% (34.82-42.94)
Injection-site haematoma[2] Listed[3] 1.45% (0.45-2.44)
Injection-site indurationb Not listed[4] 1.45 % (0.45-2.44)
Injection-site pruritusb Not listedd 7.59 % (5.39-9.80)
Injection-site warmthb Not listedd 3.98 % (2.35-5.61)
aThese AEs were solicited from Day 0 to Day 7 after Triaxis®.
bThese AEs were unsolicited from Day 0 to Day 30 after Triaxis®.
cInjection site haematoma (bruising) is listed in the SmPC with no precise frequency since it has been spontaneously reported during post marketing use from a population of uncertain size.
dInjection-site induration, pruritus and warmth were spontaneously reported during post marketing use. They have not been individually listed in the SmPC because these ISRs are commonly associated with erythema and swelling part of inflammatory local reactions.
Table 5: Comparison of the reported frequencies in the Study and the frequencies stated in the Summary of Product Characteristics of Triaxis® (Tdap5).