Table 4.
Adverse events in apabetalone versus placebo across CKD status a
| Variable | Patients without CKD by Assigned Treatment Group | Patients with CKD by Assigned Treatment Group | ||
|---|---|---|---|---|
| Placebo (eGFR ≥60 ml/min per 1.73 m2) (n=1041) | Apabetalone (eGFR ≥60 ml/min per 1.73 m2) (n=1084) | Placebo (eGFR <60 ml/min per 1.73 m2) (n=164) | Apabetalone (eGFR <60 ml/min per 1.73 m2) (n=124) | |
| Patients with at least one adverse event (%) a | 699 (67) | 739 (68) | 119 (73) | 88 (71) |
| Frequent adverse events b , c | ||||
| Acute myocardial infarction | 38 (4) | 38 (4) | 12 (7) | 4 (3) |
| Alanine aminotransferase increased | 12 (1) | 60 (6) | 6 (4) | 4 (3) |
| Angina | 65 (6) | 65 (6) | 11 (7) | 9 (7) |
| Anemia | 30 (3) | 32 (3) | 10 (6) | 4 (3) |
| Cardiac failure | 24 (2) | 19 (2) | 14 (9) | 3 (2) |
| Diarrhea | 33 (3) | 36 (3) | 11 (7) | 7 (6) |
| Hypertension | 65 (6) | 61 (6) | 7 (4) | 9 (7) |
| Nasopharyngitis | 47 (5) | 41 (4) | 9 (5) | 5 (4) |
| Pneumonia | 16 (2) | 23 (2) | 10 (6) | 4 (3) |
| Urinary tract infection | 29 (3) | 49 (5) | 11 (7) | 9 (7) |
| Unstable angina | 36 (3) | 56 (5) | 5 (3) | 2 (2) |
| Worsening diabetes mellitus | 55 (5) | 69 (6) | 7 (4) | 7 (6) |
a
Adverse events were assessed in the safety population, which includes all patients who received at least one dose of study drug medication.
b
Includes treatment-emergent adverse events only, defined as those occurring after the first dose and within 14 d of the last dose of the study drug.
c
Defined as occurring with a frequency of ≥5% in any of the CKD or treatment groups.