Table 4.
Summary of Treatment-Emergent Adverse Events by Preferred Term
| Adverse Event Preferred Term | Placebo (n = 6) n (%) |
ELND005 250 mg BID (n = 12) n (%) |
ELND005 250 mg QD (n = 5) n (%) |
TEAE Outcome (Duration) |
|---|---|---|---|---|
| Participants with at least one TEAE | 0 | 5 (41.7) | 2 (40.0) | |
| Bradycardia | 0 | 1 (8.3) | 0 | (unknown) |
| Diarrhoea | 0 | 1 (8.3) | 0 | Resolved (1 day) |
| Oral disorder | 0 | 1 (8.3) | 0 | Resolved (29 days) |
| Pseudofolliculitis barbae | 0 | 1 (8.3) | 0 | Ongoing |
| Resting tremor | 0 | 1 (8.3) | 0 | Resolved (3 days) |
| Restless legs syndrome | 0 | 1 (8.3) | 0 | Ongoing |
| Seasonal allergy | 0 | 1 (8.3) | 0 | 2 episodes, both resolved (5 days, 7 days) |
| Catheter site pain | 0 | 0 | 1 (20.0)a | Resolved (5 days) |
| Muscle strain | 0 | 0 | 1 (20.0) | Ongoing |
| Electrocardiogram abnormal | 0 | 0 | 1 (20.0) | Ongoing |
| Anger | 0 | 0 | 1 (20.0)a | Resolved (1 day) |
Abbreviations: 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.
a
These 2 events were reported by participant (001-007) who withdrew from the study on Day 7.