Table 3.
Incidence of treatment-emergent adverse events (TEAEs) in patients receiving postoperative HPβCD-diclofenac, according to MedDRA System Organ Class (SOC)
| Variable | Age group (years) | p valuea | ||
|---|---|---|---|---|
| < 65 (N = 878) | 65–74 (N = 282) | ≥ 75 (N = 129) | ||
| TEAEs, n | 2274 | 855 | 497 | – |
| Patients experiencing ≥ 1 TEAE, n (%) | 712 (81.1) | 236 (83.7) | 109 (84.5) | 0.4360 |
| Most frequent TEAEsb, n (%)c | ||||
| Blood and lymphatic system disorders | 27 (3.1) | 15 (5.3) | 9 (7.0) | 0.0390 |
| Cardiac disorders | 37 (4.2) | 17 (6.0) | 11 (8.5) | 0.1691 |
| Gastrointestinal disorders | 434 (49.4) | 140 (49.6) | 65 (50.4) | 0.9576 |
| Nausea | 283 (32.2) | 93 (33.0) | 42 (32.6) | 0.8988 |
| Constipation | 126 (14.4) | 53 (18.8) | 33 (25.6) | 0.0017 |
| Vomiting | 62 (7.1) | 24 (8.5) | 10 (7.8) | 0.7907 |
| Flatulence | 68 (7.7) | 7 (2.5) | 0 (0.0) | 0.0118 |
| General disorders and administration site conditions | 185 (21.1) | 66 (23.4) | 26 (20.2) | 0.2815 |
| Infusion site pain | 65 (7.4) | 20 (7.1) | 3 (2.3) | 0.1315 |
| Pyrexia | 44 (5.0) | 17 (6.0) | 9 (7.0) | 0.7018 |
| Edema peripheral | 24 (2.7) | 16 (5.7) | 6 (4.7) | 0.1403 |
| Infections and infestations | 78 (8.9) | 30 (10.6) | 14 (10.9) | 0.9429 |
| Injury, poisoning, and procedural complications | 161 (18.3) | 85 (30.1) | 44 (34.1) | 0.0043 |
| Anemia postoperative | 104 (11.8) | 64 (22.7) | 41 (31.8) | < 0.0001 |
| Investigations | 127 (14.5) | 43 (15.2) | 21 (16.3) | 0.8913 |
| Blood creatine phosphokinase increased | 76 (8.7) | 15 (5.3) | 7 (5.4) | 0.1604 |
| Metabolism and nutrition disorders | 52 (5.9) | 15 (5.3) | 16 (12.4) | 0.0448 |
| Musculoskeletal and connective tissue disorders | 63 (7.2) | 22 (7.8) | 16 (12.4) | 0.1588 |
| Nervous system disorders | 140 (15.9) | 28 (9.9) | 15 (11.6) | 0.0275 |
| Dizziness | 45 (5.1) | 11 (3.9) | 10 (7.8) | 0.2492 |
| Headache | 71 (8.1) | 9 (3.2) | 1 (0.8) | 0.0008 |
| Psychiatric disorders | 107 (12.2) | 48 (17.0) | 30 (23.3) | 0.0071 |
| Insomnia | 88 (10.0) | 39 (13.8) | 20 (15.5) | 0.1539 |
| Renal and urinary disorders | 31 (3.5) | 15 (5.3) | 12 (9.3) | 0.0081 |
| Respiratory, thoracic, and mediastinal disorders | 70 (8.0) | 22 (7.8) | 21 (16.3) | 0.0166 |
| Skin and subcutaneous tissue disorders | 131 (14.9) | 55 (19.5) | 21 (16.3) | 0.5326 |
| Pruritus | 91 (10.4) | 32 (11.3) | 12 (9.3) | 0.6811 |
| Vascular disorders | 78 (8.9) | 30 (10.6) | 23 (17.8) | 0.0057 |
| Hypotension | 36 (4.1) | 14 (5.0) | 17 (13.2) | 0.0003 |
MedDRA Medical Dictionary for Regulatory Activities version 12.0
aComparison of the three age groups was via Cochran–Mantel–Haenszel test
bSOC categories within which the incidence of TEAEs was > 5% for any one of the three age groups. All preferred terms with an incidence > 5% in any one of the three age groups are shown under each SOC category
cPercentages are based on the number of subjects. Subjects were counted once within each SOC category or for each preferred term and may have experienced more than one TEAE