Table 3.
Drug-related AEs by PT that occurred in ≥3% of patients in any treatment group (SAF)
| [SOC] PT | Evocalcet (n = 203) n (%) E | Cinacalcet (n = 200) n (%) E | Total (N = 403) n (%) E | P-value |
|---|---|---|---|---|
| Number of patients with at least one drug-related AE | 156 (76.8) 991 | 168 (84.0) 1390 | 324 (80.4) 2381 | 0.070 |
| [Metabolism and nutrition disorders] | 115 (56.7) 559 | 119 (59.5) 589 | 234 (58.1) 1148 | 0.562 |
| Hypocalcemia | 108 (53.2) 490 | 101 (50.5) 448 | 209 (51.9) 938 | 0.587 |
| Decreased appetite | 14 (6.9) 23 | 36 (18.0) 97 | 50 (12.4) 120 | 0.000 |
| Hypoproteinemia | 11 (5.4) 20 | 9 (4.5) 21 | 20 (5.0) 4 | 0.671 |
| [Gastrointestinal disorders] | 65 (32.0) 228 | 95 (47.5) 527 | 160 (39.7) 755 | 0.001 |
| Nausea | 25 (12.3) 49 | 49 (24.5) 157 | 74 (18.4) 206 | 0.001 |
| Vomiting | 19 (9.4) 32 | 40 (20.0) 127 | 59 (14.6) 159 | 0.002 |
| Abdominal discomfort | 23 (11.3) 51 | 35 (17.5) 77 | 58 (14.4) 128 | 0.077 |
| Abdominal distension | 16 (7.9) 39 | 31 (15.5) 70 | 47 (11.7) 109 | 0.017 |
| Diarrhea | 11 (5.4) 22 | 21 (10.5) 36 | 32 (7.9) 58 | 0.059 |
| Abdominal pain upper | 5 (2.5) 11 | 8 (4.0) 11 | 13 (3.2) 22 | 0.382 |
| Flatulence | 0 | 8 (4.0) 18 | 8 (2.0) 18 | 0.003 |
| Gastroesophageal reflux disease | 7 (3.4) 7 | 1 (0.5) 1 | 8 (2.0) 8 | 0.033 |
| [Investigations] | 40 (19.7) 133 | 44 (22.0) 173 | 84 (20.8) 306 | 0.570 |
| Blood calcium decreased | 16 (7.9) 31 | 18 (9.0) 50 | 34 (8.4) 81 | 0.686 |
| Electrocardiogram QT prolonged | 15 (7.4) 29 | 18 (9.0) 48 | 33 (8.2) 77 | 0.555 |
| Calcium ionized decreased | 9 (4.4) 65 | 9 (4.5) 59 | 18 (4.5) 124 | 0.974 |
| [Musculoskeletal and connective tissue disorders] | 8 (3.9) 12 | 8 (4.0) 22 | 16 (4.0) 34 | 0.975 |
| Muscle spasms | 5 (2.5) 9 | 6 (3.0) 18 | 11 (2.7) 27 | 0.740 |
| [Nervous system disorders] | 6 (3.0) 7 | 9 (4.5) 14 | 15 (3.7) 21 | 0.412 |
| Dizziness | 0 | 7 (3.5) 10 | 7 (1.7) 10 | 0.007 |
AE, adverse event; PT, preferred term; SAF, safety analysis set; SOC, system organ class.
“n” represents the number of patients, % is the percentage of patients in each category, and E represents the number of drug-related AEs. AEs were defined as AEs that started or worsened in severity on or after the first dose of study medication. MedDRA Version 24.0 was used to code AEs. All P-values were calculated by chi-squared test.