Table 2.
Overview of adverse events (AEs) and adverse drug reactions (ADRs) that occurred during the study period in the safety collective.
| Echinaforce (N = 355) |
Placebo (N = 362) |
Total (N = 717) |
|
|---|---|---|---|
| Number (%) of participants with | |||
| (i) adverse events | 177 (49.9) | 172 (47.5) | 349 (48.7) |
| (ii) drug-related AEs1 | 35 (9.9) | 35 (9.7) | 70 (9.8) |
| (iii) serious AEs | 0 (0.0) | 1 (0.3) | 1 (0.1) |
| (iv) AEs leading to treatment discontinuation | 3 (0.8) | 2 (0.6) | 5 (0.7) |
| Number of events2 | |||
| (i) adverse events | 293 | 306 | 599 |
| (ii) drug-related AEs1 | 39 | 36 | 75 |
| (iii) serious adverse events |
0 | 1 | 1 |
| (iv) AEs leading to treatment discontinuation | 4 | 3 | 7 |
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.