Table 4.

Adverse events in safety analysis set

Adverse EventsEtelcalcetide Group, n=165Maxacalcitol Group, n=159
Serious adverse events
 Any serious adverse events41 (32; 19%)70 (44; 28%)
 All-cause death5 (5; 3%)6 (6; 4%)
 Any hospitalization38 (30; 18%)65 (40; 25%)
 Cardiac events8 (5; 3%)4 (4; 3%)
 Cerebrovascular events1 (1; 1%)6 (6; 4%)
 Peripheral vascular event9 (9; 5%)14 (10; 6%)
 Infectious disease3 (3; 2%)20 (14; 9%)
 Malignancy3 (3; 2%)10 (6; 4%)
 Other serious adverse events17 (15; 9%)16 (13; 8%)
Symptoms
 Nausea11 (9; 5%)24 (17; 11%)
 Vomiting10 (8; 5%)16 (12; 8%)
 Dysgeusia/cacogeusia7 (4; 2%)5 (3; 2%)
 Diarrhea22 (16; 10%)10 (7; 4%)
 Itching58 (30; 18%)72 (38; 24%)
 Irritability/jitteriness20 (15; 9%)24 (16; 10%)
Falls47 (28; 17%)38 (27; 17%)
Hypercalcemia requiring temporal cessation of study drug0 (0; 0%)10 (10; 6%)
Hypocalcemia requiring temporal cessation of study drug33 (30; 18%)0 (0; 0%)
  • The table gives numbers of event (number of patients; percentage of participants) by group. Some patients had repeated adverse events in the same category.