Research Article

Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial

Table 2

Overview of adverse events (AEs) and adverse drug reactions (ADRs) that occurred during the study period in the safety collective.

Echinaforce  
( 𝑁 = 3 5 5 )
Placebo  
( 𝑁 = 3 6 2 )
Total  
( 𝑁 = 7 1 7 )

Number (%) of participants with
 (i) adverse events177 (49.9)172 (47.5)349 (48.7)
 (ii) drug-related AEs135 (9.9)35 (9.7)70 (9.8)
 (iii) serious AEs0 (0.0)1 (0.3)1 (0.1)
 (iv) AEs leading to treatment discontinuation3 (0.8)2 (0.6)5 (0.7)
Number of events2
 (i) adverse events293306599
 (ii) drug-related AEs1393675
 (iii) serious adverse
    events
011
 (iv) AEs leading to treatment discontinuation437

1AEs that were causally related to the study medication with ratings of certain, probable/likely, or possible.
2AEs were based on the Preferred Terms (PTs), each PT counted only once per participant.