Table 5

Adverse events (AEs) per treatment (safety analysis set, N=148)*

Verum (n=73)Placebo (n=75)
EventsPatients (%)EventsPatients (%)
AE4118 (24.7)5021 (28.0)
Related AE†11 (1.4)72 (2.7)
Serious AE11 (1.4)‡00
Mild AE§3211 (15.1)3819 (25.3)
Moderate AE¶87 (9.6)127 (9.3)
Severe AE**11 (1.4)00
Most frequent AEs††
 Headache177 (4.7)137 (4.7)
 Back pain00106 (4.1)
 Nasopharyngitis00106 (4.1)
  • *The safety analysis set includes all randomised patients who received the study drug at least once.

  • †At least reasonable possibility of causal relationship to study drug.

  • ‡The patient was admitted to hospital due to ‘chest pain’, AE was severe but not related to the study drug.

  • §Mild: normal functional level not impaired or only slightly impaired.

  • ¶Moderate: normal functional level to a certain extent impaired.

  • **Severe: normal functional level markedly impaired.

  • ††Events in at least four study participants overall, all not related.