Table 2. Treatment-emergent adverse events occurring in ≥ 5% of patients in the etelcalcetide arms, adverse events leading to discontinuation, and serious adverse events.
| Placebo-Controlled Trials | Active-Controlled Trial | Open-Label Extension Trials | |||
|---|---|---|---|---|---|
| Preferred Term | Placebo (n = 513) n (%) |
Etelcalcetide (n = 503) n (%) |
Cinacalcet (n = 341) n (%) |
Etelcalcetide (n = 338) n (%) |
Etelcalcetide (n = 1298) n (%) |
| Number of patients with reported treatment-emergent AEs | 410 (79.9) | 461 (91.7) | 307 (90.0) | 314 (92.9) | 1177 (90.7) |
| Blood calcium decreased | 52 (10.1) | 321 (63.8) | 204 (59.8) | 233 (68.9) | 565 (43.5) |
| Diarrhea | 44 (8.6) | 54 (10.7) | 35 (10.3) | 21 (6.2) | 168 (12.9) |
| Nausea | 32 (6.2) | 54 (10.7) | 77 (22.6) | 62 (18.3) | 137 (10.6) |
| Vomiting | 26 (5.1) | 45 (8.9) | 47 (13.8) | 45 (13.3) | 139 (10.7) |
| Muscle spasms | 34 (6.6) | 58 (11.5) | 20 (5.9) | 22 (6.5) | 137 (10.6) |
| Hypotension | 26 (5.1) | 30 (6.0) | 10 (2.9) | 23 (6.8) | 131 (10.1) |
| Hypertension | 29 (5.7) | 31 (6.2) | 23 (6.7) | 21 (6.2) | 126 (9.7) |
| Hyperphosphatemia | 9 (1.8) | 9 (1.8) | 10 (2.9) | 10 (3.0) | 113 (8.7) |
| Arteriovenous fistula site complication | 26 (5.1) | 29 (5.8) | 6 (1.8) | 9 (2.7) | 104 (8.0) |
| Upper respiratory tract infection | 26 (5.1) | 21 (4.2) | 15 (4.4) | 10 (3.0) | 104 (8.0) |
| Pain in extremity | 20 (3.9) | 24 (4.8) | 14 (4.1) | 17 (5.0) | 102 (7.9) |
| Dyspnea | 20 (3.9) | 24 (4.8) | 14 (4.1) | 14 (4.1) | 101 (7.8) |
| Back pain | 19 (3.7) | 22 (4.4) | 10 (2.9) | 9 (2.7) | 97 (7.5) |
| Headache | 31 (6.0) | 38 (7.6) | 24 (7.0) | 22 (6.5) | 93 (7.2) |
| Arthralgia | 26 (5.1) | 21 (4.2) | 7 (2.1) | 7 (2.1) | 93 (7.2) |
| Hyperkalemia | 11 (2.1) | 22 (4.4) | 15 (4.4) | 13 (3.8) | 93 (7.2) |
| Cough | 22 (4.3) | 22 (4.4) | 9 (2.6) | 10 (3.0) | 94 (7.2) |
| Anemia | 22 (4.3) | 19 (3.8) | 15 (4.4) | 17 (5.0) | 86 (6.6) |
| Abdominal pain | 15 (2.9) | 13 (2.6) | 13 (3.8) | 13 (3.8) | 79 (6.1) |
| Viral upper respiratory tract infection | 0 | 2 (0.4) | 0 | 1 (0.3) | 78 (6.0) |
| Pneumonia | 17 (3.3) | 11 (2.2) | 3 (0.9) | 6 (1.8) | 77 (5.9) |
| Fall | 14 (2.7) | 15 (3.0) | 8 (2.3) | 3 (0.9) | 76 (5.9) |
| Pyrexia | 20 (3.9) | 20 (4.0) | 8 (2.3) | 12 (3.6) | 75 (5.8) |
| Fluid overload | 11 (2.1) | 16 (3.2) | 7 (2.1) | 7 (2.1) | 66 (5.1) |
| Hypocalcemia | 1 (0.2) | 35 (7.0) | 8 (2.3) | 17 (5.0) | 37 (2.9) |
| Patient incidence of treatment-emergent AEs leading to discontinuation of investigational product | 13 (2.5) | 9 (1.8) | 16 (4.7) | 19 (5.6) | 39 (3.0)a |
| Number of patients reporting serious treatment-emergent AEs | 149 (29.0) | 130 (25.8) | 93 (27.3) | 85 (25.1) | 671 (51.7) |
| Hyperkalemia | 2 (0.4) | 10 (2.0) | 5 (1.5) | 1 (0.3) | 43 (3.5) |
| Pneumonia | 14 (2.7) | 10 (2.0) | 1 (0.3) | 1 (0.3) | 56 (4.3) |
| Angina pectoris | 3 (0.6) | 7 (1.4) | 1 (0.3) | 1 (0.3) | 15 (1.2) |
| Fluid overload | 7 (1.4) | 6 (1.2) | 1 (0.3) | 2 (0.6) | 26 (2.0) |
| Atrial fibrillation | 5 (1.0) | 5 (1.0) | 2 (0.6) | 0 | 28 (2.2) |
| Cardiac failure congestive | 5 (1.0) | 5 (1.0) | 1 (0.3) | 0 | 24 (1.8) |
| Sepsis | 4 (0.8) | 4 (0.8) | 4 (1.2) | 3 (0.9) | 42 (3.2) |
| Vascular graft thrombosis | 5 (1.0) | 3 (0.6) | 3 (0.9) | 0 | 15 (1.2) |
| Arteriovenous fistula thrombosis | 5 (1.0) | 2 (0.4) | 1 (0.3) | 1 (0.3) | 33 (2.5) |
| Gangrene | 2 (0.4) | 2 (0.4) | 0 | 4 (1.2) | 9 (0.7) |
| Anemia | 5 (1.0) | 1 (0.2) | 4 (1.2) | 0 | 24 (1.8) |
AE = adverse event.
aBased on N = 1289.