Table 3.
All-causality AEs in PA and non-PA patients
| PA (n=448)a
|
Non-PA (n=969)a
|
|||
|---|---|---|---|---|
| PMI arm (n=247) | UC arm (n=201) | PMI arm (n=513) | UC arm (n=456) | |
| Number of AEs, n | 354 | 266 | 365 | 327 |
| Patients with AEs, n (%) | 137 (55.5) | 124 (61.7) | 23 (45.2) | 172 (37.7) |
| Serious AEs,b n (%) | 19 (7.7) | 8 (4.0) | 31 (6.0) | 13 (2.9) |
| Severe AEs,c n (%) | 13 (5.3) | 6 (3.0) | 27 (5.3) | 10 (2.2) |
| Discontinued due to AEs, n (%) | 7 (2.8) | 0 (0.0) | 38 (7.4) | 4 (0.9) |
| Dose reduced or temporarily discontinued, n (%) | 8 (3.2) | 0 (0.0) | 16 (3.1) | 6 (1.3) |
| Most frequent AEsd | ||||
| Edema peripheral, n (%) | 15 (6.1) | 1 (0.5) | 36 (7.0) | 10 (2.2) |
| Hypercholesterolemia, n (%) | 0 (0.0) | 11 (5.5) | 1 (0.2) | 1 (0.2) |
| Headache, n (%) | 10 (4.0) | 7 (3.5) | 13 (2.5) | 8 (1.8) |
| Dyslipidemia, n (%) | 0 (0.0) | 8 (4.0) | 0 (0.0) | 3 (0.7) |
| Nasopharyngitis, n (%) | 12 (4.9) | 4 (2.0) | 10 (1.9) | 6 (1.3) |
| Chest pain, n (%) | 13 (5.3) | 7 (3.5) | 4 (0.8) | 3 (0.7) |
| Increase in TG, n (%) | 2 (0.8) | 5 (2.5) | 9 (1.8) | 9 (2.0) |
| Bronchitis, n (%) | 3 (1.2) | 0 (0.0) | 9 (1.8) | 15 (3.3) |
| Dizziness, n (%) | 10 (4.0) | 7 (3.5) | 6 (1.2) | 2 (0.4) |
| Upper respiratory tract infection, n (%) | 16 (6.5) | 10 (5.0) | 0 (0.0) | 4 (0.9) |
| Increase in creatine phosphokinase, n (%) | 4 (1.6) | 3 (1.5) | 11 (2.1) | 2 (0.4) |
| Dyspepsia, n (%) | 3 (1.2) | 5 (2.5) | 2 (0.4) | 5 (1.1) |
| Constipation, n (%) | 6 (2.4) | 3 (1.5) | 3 (0.6) | 1 (0.2) |
| Arthralgia, n (%) | 6 (2.4) | 4 (2.0) | 3 (0.6) | 4 (0.9) |
| Hyperlipidemia, n (%) | 0 (0.0) | 9 (4.5) | 0 (0.0) | 1 (0.2) |
| Insomnia, n (%) | 6 (2.4) | 7 (3.5) | 2 (0.4) | 4 (0.9) |
| Hypertension, n (%) | 2 (0.8) | 2 (1.0) | 2 (0.4) | 10 (2.2) |
| Pharyngitis, n (%) | 2 (0.8) | 1 (0.5) | 4 (0.8) | 12 (2.6) |
| Palpitations, n (%) | 7 (2.8) | 3 (1.5) | 1 (0.2) | 2 (0.4) |
| Abdominal pain upper, n (%) | 6 (2.4) | 4 (2.0) | 1 (0.2) | 3 (0.7) |
| Chest discomfort, n (%) | 5 (2.0) | 4 (2.0) | 0 (0.0) | 0 (0.0) |
| Osteoarthritis, n (%) | 7 (2.8) | 3 (1.5) | 3 (0.6) | 5 (1.1) |
| Back pain, n (%) | 5 (2.0) | 5 (2.5) | 6 (1.2) | 1 (0.2) |
| Cough, n (%) | 7 (2.8) | 6 (3.0) | 2 (0.4) | 2 (0.4) |
| Hypoesthesia, n (%) | 6 (2.4) | 0 (0.0) | 1 (0.2) | 0 (0.0) |
| Hyperuricemia, n (%) | 0 (0.0) | 4 (2.0) | 0 (0.0) | 0 (0.0) |
| Myalgia, n (%) | 2 (0.8) | 4 (2.0) | 4 (0.8) | 1 (0.2) |
Notes:
a
Safety population: all randomized patients who received at least one dose of study medication
b
serious AEs are defined as meeting one of the following criteria: AE resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or in congenital anomaly or birth defect
c
severe AEs are defined as AEs that interfere significantly with a patient’s usual function
d
all observed or self-reported AEs that occurred at a rate of ≥2%.
Abbreviations: AEs, adverse events; PA, Pacific Asian; PMI, proactive multifactorial intervention; TG, triglycerides; UC, usual care.