Table 2.
Part 1 (Cohorts 1–6) | Part 2 (Cohort 7) | |||
---|---|---|---|---|
Placebo (n = 24) | Trabodenoson (n = 36) | Placebo (n = 4) | Trabodenoson (n = 6) | |
Any AE | 21 (87.5) | 18 (50.0) | 1 (25.0) | 3 (50.0) |
Related AE | 6 (25.0) | 10 (27.8) | 1 (25.0) | 1 (16.7) |
Serious AEa | 1 (4.2) | — | — | — |
AE resulting in discontinuation | 2 (8.3) | 1 (2.8)b | — | — |
One serious AE of mild supraventricular tachycardia occurred in a subject assigned to placebo in Cohorts 1–6 and led to study discontinuation.
One subject assigned to trabodenoson in cohorts 1–6 was discontinued due to active chronic cholecystitis.
AE, adverse event.