| SAEs |
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Severe shunt occlusion in 2 patients, intraocular lens dislocation in 1 patient13
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Incidence of SAEs in Japanese HD patients was 15% vs. 27% with DPO; similar incidences of all SAEs for both groups, including shunt stenosis (3% vs. 4% with DPO) and shunt occlusion (<1% vs. 2% with DPO)14
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Incidence of SAEs in Chinese patients is consistent with those observed in CKD patients (8.9% vs. 11.7% with PBO; 1 patient with serious hyperkalemia and 2 patients with serious metabolic acidosis)23
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Incidence of SAEsa in Japanese patients was 11.1% in all patients (2.0% drug related; 6.1% leading to treatment discontinuation)88
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OLYMPUS trial: incidence of all-cause mortality was 20.5% vs. 17.8% with PBO, and of SAEs was 57.4% vs. 54.4% with PBOa
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Incidence of SAEs in Chinese patients was 14.2% vs. 10% with epoetin alfa; most frequent SAE was vascular access complication (2.9% vs. 3.0% with epoetin alfa)22
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Increased incidence of serious thromboembolic events based on PMDA safety data review of pooled Japanese phase 3 trials (8.2% vs. 2.6% for DPO)141
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Incidence of SAEs in Japanese stable HD patients was 20.7% vs. 14.5% with DPO (drug related, 3.3% vs. 3.9%; leading to treatment discontinuation, 8.7% vs. 5.3%)18
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SAEs reported in 29.3% of EPO-naïve and 28.2% of EPO-converted incident HD patients from Japan16
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Incidence of SAEs in Japanese PD patients was 23.1% in ESA-naïve and 11.6% in ESA-converted patients; most common SAE was peritonitis (3.6% overall)17
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PYRENEES trial: incidence of all-cause mortality was 18.8% vs. 14.1% with ESA, and of SAEs was 50.7% vs. 45.0% with ESAb
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ROCKIES trial: incidence of all-cause mortality was 23.6% vs. 21.9% with epoetin alfa, and of SAEs was 57.6% vs. 57.6% with epoetin alfac
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| Most common AEs |
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Nasopharyngitis (33% vs. 37% with CERA), constipation (7% vs. 12% with CERA), no difference in prespecified ocular, CV, and cancer-related AEs15
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Similar incidence between newly started and established HD patients, most commonly reported were nasopharyngitis, infected dermal cysts, mild to moderate shunt stenosis13
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In Japanese HD patients, higher incidence of diarrhea (15% vs. 9% with DPO) and contusion (13% vs. 8% with DPO), lower incidence of nasopharyngitis (42% vs. 54% with DPO) and pain in extremity (<1% vs. 7% with DPO); incidence of hyperkalemia was 3% vs. 1% with DPO, but no clinically relevant change in potassium from baseline in either group; similar incidence of adverse ocular events with DAPRO vs. DPO14
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ESA-naïve: AE incidence was 84.1% vs. 91.1% with DPO; nasopharyngitis (20.7% vs. 25.3% with DPO), worsening CKD (13.4% vs. 6.3% with DPO)86
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ESA-converted: AE incidence was 87.8% vs. 89% with DPO; nasopharyngitis (28.3% vs. 30.5% with DPO), worsening CKD (12.2% vs. 7.3% with DPO)87
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Hyperkalemia (15.8% vs. 7.8% with PBO), metabolic acidosis (11.9% vs. 2.0% with PBO), hypertension (5.9% vs. 3.9% with PBO), peripheral edema (6.9% vs. 5.9% for PBO) in Chinese patients23
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Most frequent (≥5%) AEsd in Japanese patients were nasopharyngitis (20.2%), hyperkalemia (5.1%), and hypertension (6.1%)88
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ALPS trial: common AEs were ESRD, hypertension, peripheral edema, and decreased GFR90
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OLYMPUS trial: most common AEs were UTI (11.0% vs. 6.8% with PBO), hypertension (10.7% vs. 8.5% with PBO), peripheral edema (10.4% vs. 7.7% with PBO), and diarrhea (10.0% vs. 8.5% with PBO)a
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Increased frequency of upper respiratory infection compared with epoetin alfa (18.1% vs. 11.0%), and hyperkalemia (7.4% vs. 1.0%) in Chinese patients22
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In Japanese HD patients, common (≥10%) AEs were nasopharyngitis, (20.0%) and contact dermatitis (13.3%) in EPO-naïve patients, and nasopharyngitis (52.8%), diarrhea (11.0%), and vomiting (10.4%) in ESA-converted patients16
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Nasopharyngitis (34.7% vs. 26.3% with DPO), new or worsening retinal hemorrhage (32.4% vs. 36.6% with DPO), shunt stenosis (7.3% vs. 8.6% with DPO), GI disorders (28.0% vs. 18.4% with DPO) in Japanese HD patients18
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Higher incidence of AEs in Japanese ESA-converted vs. ESA-naïve PD patients, including nasopharyngitis, catheter site infection, and GI disorders; also reported back pain17
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PYRENEES trial: common AEs were hypertension, AV fistula thrombosis, headache, and diarrhea90
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ROCKIES trial: most common AE was diarrhea (10.9% vs. 9.6% with epoetin alfa)c
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Nasopharyngitis (14.6% vs. 12.4% with DPO), diarrhea (10.6% vs. 3.3% with DPO), and constipation (5.3% vs. 3.9% with DPO)19
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PRO2TECT trial: most common AEs were ESRD (34.7% vs. 35.2% with DPO), hypertension (17.7% vs. 22.1% with DPO), hyperkalemia (12.3% vs. 15.6% with DPO) in the Correction study, and ESRD (27.5% vs. 28.4% with DPO), hypertension (14.4% vs. 14.8% with DPO), urinary tract infection (12.2% vs. 14.5% with DPO) in the Conversion study113
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Nasopharyngitis (19.8% vs. 28.6% with DPO), diarrhea (10.5% vs. 9.9% with DPO), and shunt stenosis (8.0% vs. 12.4% with DPO)20
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INNO2VATE trial: most common AEs were hypertension (16.2% vs. 12.9% with DPO) and diarrhea (10.1% vs. 9.7% with DPO) in I-DD-CKD, and diarrhea (13.0% vs. 10.1% with DPO), pneumonia (11.0% vs. 9.7% with DPO), hypertension (10.6% vs. 13.8% with DPO), and hyperkalemia (9.0% vs. 10.8% with DPO) in M-DD-CKD142
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