Table 5.
Clinical findings in dogs of treated and control groups following the first treatment
| Observation | Number of dogs affected | Analysis | Conclusion |
|---|---|---|---|
| Scattered incidences of abnormal feces (loose, mucoid, traces of fresh blood) |
Total observed: n = 15 |
Similar number of animals affected in each treated group compared to controls; abnormal feces already observed pre-treatment across all groups |
Not treatment related, no adverse event |
| Control group: n = 4 | |||
| 1X group: n = 5 | |||
| 3X group: n = 3 | |||
| 5X group: n = 3 | |||
| Reduced body condition score (2 or 2–3 on a scale of 1–5) |
Total observed: n = 8 |
Similar (3X group, 5X group) or lower (1X group) number of animals affected compared to controls; no dose–response relationship |
Not treatment related, no adverse event |
| Control group: n = 3 | |||
| 1X group: n = 0 | |||
| 3X group: n = 3 | |||
| 5X group: n = 2 | |||
| Localized hair thinning/pressure wound/wound |
Total observed: n = 6 |
Similar (1X group, 5X group) or lower (3X group) number of animals affected compared to controls; no dose–response relationship |
Not treatment related, no adverse event |
| Control group: n = 2 | |||
| 1X group: n = 3 | |||
| 3X group: n = 0 | |||
| 5X group: n = 1 | |||
| Vomiting of food after first treatment, no other clinical findings |
Total observed: n = 1 |
Single case; no dose–response relationship; not observed following repeated treatment |
Not treatment related, no adverse event |
| Control group: n = 0 | |||
| 1X group: n = 1 | |||
| 3X group: n = 0 | |||
| 5X group: n = 0 | |||
| Gastroenteritis with inappetence, dullness, vomit | Total observed: n = 1 |
Single case; no dose–response relationship; not observed following repeated treatment | Not treatment related, no adverse event |
| Control group: n = 0 | |||
| 1X group: n = 0 | |||
| 3X group: n = 1 | |||
| 5X group: n = 0 |