AE category | Treatment |
|---|
OM3-CA 2 g (n = 7) n (%) | OM3-CA 4 g (n = 6) n (%) | OM3-EE 4 g (n = 15) n (%) |
|---|
Treatment-emergent AEsa | 5 | 5 | 6 |
Mild | 4 | 3 | 5 |
Moderate | 1 | 2 | 1 |
Severe | 0 | 0 | 0 |
Led to discontinuation | 0 | 0 | 0 |
Related to study drugb | 3 | 2 | 1 |
Diarrhea | 1 | 2 | 0 |
Nausea | 1 | 0 | 0 |
Abdominal distention | 0 | 0 | 1 |
Abdominal pain | 0 | 1 | 0 |
Dyspepsia | 1 | 0 | 0 |
Somnolence | 0 | 0 | 1 |
SAEs | 0 | 0 | 0 |
- Data are for the safety population, defined as all participants who took at least one dose of study drug (n = 15). aA treatment-related AE was defined as any that started during treatment period I or II, or that was ongoing from the screening/washout period and subsequently worsened. bThe number of patients experiencing drug-related treatment-emergent AEs does not always equal the total number of different types of AEs by system organ class and preferred terms because more than one type of AE could be experienced by the same patient. OM3-CA omega-3 carboxylic acids, OM3-EE omega-3 ethyl esters, SAE serious adverse event
