Table 3.
Overview of Adverse Events
| Placebo (n = 6) n (%) |
ELND005 250 mg BID (n = 12) n (%) |
ELND005 250 mg QD (n = 5) n (%) |
|
|---|---|---|---|
| Participants with | |||
| Any TEAE | 0 | 5 (41.7) | 2 (40.0) |
| Any drug-related TEAE | 0 | 1 (8.3) | 0 |
| Serious AEs | 0 | 0 | 0 |
| Serious drug-related AEs | 0 | 0 | 0 |
| Participants withdrawn due to an AE | |||
| TEAE | 0 | 0 | 1 (20.0) |
| Drug-related TEAE | 0 | 0 | 0 |
| TEAEs by maximum intensity | |||
| Mild | 0 | 5 (41.7) | 2 (40.0) |
| Moderate | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 |
| Life threatening | 0 | 0 | 0 |
| Fatal | 0 | 0 | 0 |
| Total | 0 | 5 (41.7) | 2 (40.0) |
| Drug-related TEAEs by maximum intensity | |||
| Mild | 0 | 1 (8.3) | 0 |
| Moderate | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 |
| Life threatening | 0 | 0 | 0 |
| Fatal | 0 | 0 | 0 |
| Total | 0 | 1 (8.3) | 0 |
| Deaths | 0 | 0 | 0 |
Abbreviations: AE = adverse event; BID = twice daily; QD = once daily; TEAE = treatment-emergent adverse event.
Note: A participant with more than one event in the same category is counted only once in that category. A participant may appear in multiple categories. TEAEs from the same category are counted as reported and may appear multiple times in any category.