TABLE 5.
Type and frequency of adverse events grouped according to system organ class based on the full analysis set (SAF) population (n = 82)
| Type | Pimobendan (n = 43) | Placebo (n = 39) | ||||
|---|---|---|---|---|---|---|
| F | N | % | F | N | % | |
| Cardiovascular | 51 | 25 | 58.1 | 56 | 24 | 61.5 |
| General | 14 | 9 | 20.9 | 12 | 11 | 28.2 |
| Renal | 13 | 6 | 14.0 | 12 | 7 | 17.9 |
| Gastrointestinal | 12 | 8 | 18.6 | 14 | 8 | 20.5 |
| Dermal | 4 | 3 | 7.0 | 3 | 3 | 7.7 |
| Behavioral | 1 | 1 | 2.3 | 2 | 2 | 5.1 |
| Blood | 1 | 1 | 2.3 | 0 | 0 | 0.0 |
| Hepatic | 1 | 1 | 2.3 | 0 | 0 | 0.0 |
| Neurologic | 0 | 0 | 0.0 | 1 | 1 | 2.6 |
| Respiratory | 0 | 0 | 0.0 | 1 | 1 | 2.6 |
Notes: Because of the coding process multiple adverse events at the same time in the same animal have been split into single adverse events. The adverse event type “General” includes nonspecific clinical signs such as lethargy, intermittent shaking, urinating outside the litter box, inappetence, fluctuating appetite, and other nonorgan specific client observations according to coding principles of the Veterinary Dictionary for Drug Related Affairs (VeDDRa) terminology of the European Medicines Agency.
Abbreviations: %, percent cats with at least 1 adverse event; F, frequency (number) of adverse events; N, number of cats with at least 1 adverse events.