Overall summary of TEAEs, and SAEs and TEAEs occurring in ≥10% of patients receiving peritoneal dialysis at baseline in the INNO2VATE trials (safety analysis set).
| . | Vadadustat (N = 152; exposure = 242.0 PY) . | Darbepoetin alfa (N = 157; exposure = 262.2 PY) . | ||
|---|---|---|---|---|
| Category . | n (%) . | Events (events per 100 PY) . | n (%) . | Events (events per 100 PY) . |
| Overall summary of TEAEs | ||||
| Any TEAEs | 134 (88.2) | 1069 (441.7) | 150 (95.5) | 1464 (558.4) |
| Any drug-related TEAEs | 15 (9.9) | 25 (10.3) | 8 (5.1) | 9 (3.4) |
| Any severe TEAEs | 52 (34.2) | 148 (61.2) | 75 (47.8) | 218 (83.1) |
| Any serious TEAEs | 80 (52.6) | 263 (108.7) | 115 (73.2) | 347 (132.3) |
| Any serious TEAE resulting in hospitalization | 77 (50.7) | 235 (97.1) | 113 (72.0) | 328 (125.1) |
| Any drug-related serious TEAEs | 2 (1.3) | 2 (0.8) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to trial treatment discontinuation | 6 (3.9) | 6 (2.5) | 5 (3.2) | 5 (1.9) |
| Any drug-related TEAEs leading to trial treatment discontinuation | 4 (2.6) | 4 (1.7) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to death | 16 (10.5) | 16 (6.6) | 19 (12.1) | 19 (7.2) |
| All deaths | 16 (10.5) | 16 (6.6) | 20 (12.7) | 20 (7.6) |
| TEAEs occurring in ≥10% of patients | ||||
| Infections | 84 (55.3) | 235 (97.1) | 109 (69.4) | 309 (117.8) |
| Peritonitis | 27 (17.8) | 34 (14.0) | 43 (27.4) | 53 (20.2) |
| Nasopharyngitis | 21 (13.8) | 28 (11.6) | 20 (12.7) | 29 (11.1) |
| Pneumonia | 18 (11.8) | 22 (9.1) | 17 (10.8) | 18 (6.9) |
| Gastrointestinal disorders | 61 (40.1) | 126 (52.1) | 74 (47.1) | 164 (62.5) |
| Metabolism and nutrition disorders | 56 (36.8) | 94 (38.8) | 79 (50.3) | 172 (65.6) |
| Hyperkalemia | 9 (5.9) | 10 (4.1) | 22 (14.0) | 26 (9.9) |
| Vascular disorders | 47 (30.9) | 70 (28.9) | 58 (36.9) | 94 (35.9) |
| Hypertension | 22 (14.5) | 25 (10.3) | 30 (19.1) | 33 (12.6) |
| General disorders and administration-site conditions | 58 (38.2) | 74 (30.6) | 44 (28.0) | 77 (29.4) |
| Asthenia | 16 (10.5) | 21 (8.7) | 7 (4.5) | 11 (4.2) |
| Nervous system disorders | 43 (28.3) | 63 (26.0) | 41 (26.1) | 64 (24.4) |
| Injury, poisoning, and procedural complications | 38 (25.0) | 77 (31.8) | 45 (28.7) | 88 (33.6) |
| Musculoskeletal and connective tissue disorders | 36 (23.7) | 48 (19.8) | 47 (29.9) | 75 (28.6) |
| Respiratory, thoracic, and mediastinal disorders | 32 (21.1) | 50 (20.7) | 42 (26.8) | 57 (21.7) |
| Cardiac disorders | 29 (19.1) | 60 (24.8) | 40 (25.5) | 76 (29.0) |
| Skin and subcutaneous tissue disorders | 21 (13.8) | 22 (9.1) | 31 (19.7) | 41 (15.6) |
| Blood and lymphatic system disorders | 15 (9.9) | 22 (9.1) | 25 (15.9) | 37 (14.1) |
| Psychiatric disorders | 14 (9.2) | 14 (5.8) | 23 (14.6) | 29 (11.1) |
| Eye disorders | 15 (9.9) | 18 (7.4) | 16 (10.2) | 24 (9.2) |
| . | Vadadustat (N = 152; exposure = 242.0 PY) . | Darbepoetin alfa (N = 157; exposure = 262.2 PY) . | ||
|---|---|---|---|---|
| Category . | n (%) . | Events (events per 100 PY) . | n (%) . | Events (events per 100 PY) . |
| Overall summary of TEAEs | ||||
| Any TEAEs | 134 (88.2) | 1069 (441.7) | 150 (95.5) | 1464 (558.4) |
| Any drug-related TEAEs | 15 (9.9) | 25 (10.3) | 8 (5.1) | 9 (3.4) |
| Any severe TEAEs | 52 (34.2) | 148 (61.2) | 75 (47.8) | 218 (83.1) |
| Any serious TEAEs | 80 (52.6) | 263 (108.7) | 115 (73.2) | 347 (132.3) |
| Any serious TEAE resulting in hospitalization | 77 (50.7) | 235 (97.1) | 113 (72.0) | 328 (125.1) |
| Any drug-related serious TEAEs | 2 (1.3) | 2 (0.8) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to trial treatment discontinuation | 6 (3.9) | 6 (2.5) | 5 (3.2) | 5 (1.9) |
| Any drug-related TEAEs leading to trial treatment discontinuation | 4 (2.6) | 4 (1.7) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to death | 16 (10.5) | 16 (6.6) | 19 (12.1) | 19 (7.2) |
| All deaths | 16 (10.5) | 16 (6.6) | 20 (12.7) | 20 (7.6) |
| TEAEs occurring in ≥10% of patients | ||||
| Infections | 84 (55.3) | 235 (97.1) | 109 (69.4) | 309 (117.8) |
| Peritonitis | 27 (17.8) | 34 (14.0) | 43 (27.4) | 53 (20.2) |
| Nasopharyngitis | 21 (13.8) | 28 (11.6) | 20 (12.7) | 29 (11.1) |
| Pneumonia | 18 (11.8) | 22 (9.1) | 17 (10.8) | 18 (6.9) |
| Gastrointestinal disorders | 61 (40.1) | 126 (52.1) | 74 (47.1) | 164 (62.5) |
| Metabolism and nutrition disorders | 56 (36.8) | 94 (38.8) | 79 (50.3) | 172 (65.6) |
| Hyperkalemia | 9 (5.9) | 10 (4.1) | 22 (14.0) | 26 (9.9) |
| Vascular disorders | 47 (30.9) | 70 (28.9) | 58 (36.9) | 94 (35.9) |
| Hypertension | 22 (14.5) | 25 (10.3) | 30 (19.1) | 33 (12.6) |
| General disorders and administration-site conditions | 58 (38.2) | 74 (30.6) | 44 (28.0) | 77 (29.4) |
| Asthenia | 16 (10.5) | 21 (8.7) | 7 (4.5) | 11 (4.2) |
| Nervous system disorders | 43 (28.3) | 63 (26.0) | 41 (26.1) | 64 (24.4) |
| Injury, poisoning, and procedural complications | 38 (25.0) | 77 (31.8) | 45 (28.7) | 88 (33.6) |
| Musculoskeletal and connective tissue disorders | 36 (23.7) | 48 (19.8) | 47 (29.9) | 75 (28.6) |
| Respiratory, thoracic, and mediastinal disorders | 32 (21.1) | 50 (20.7) | 42 (26.8) | 57 (21.7) |
| Cardiac disorders | 29 (19.1) | 60 (24.8) | 40 (25.5) | 76 (29.0) |
| Skin and subcutaneous tissue disorders | 21 (13.8) | 22 (9.1) | 31 (19.7) | 41 (15.6) |
| Blood and lymphatic system disorders | 15 (9.9) | 22 (9.1) | 25 (15.9) | 37 (14.1) |
| Psychiatric disorders | 14 (9.2) | 14 (5.8) | 23 (14.6) | 29 (11.1) |
| Eye disorders | 15 (9.9) | 18 (7.4) | 16 (10.2) | 24 (9.2) |
PY, patient-years; SAEs, serious adverse events.
Overall summary of TEAEs, and SAEs and TEAEs occurring in ≥10% of patients receiving peritoneal dialysis at baseline in the INNO2VATE trials (safety analysis set).
| . | Vadadustat (N = 152; exposure = 242.0 PY) . | Darbepoetin alfa (N = 157; exposure = 262.2 PY) . | ||
|---|---|---|---|---|
| Category . | n (%) . | Events (events per 100 PY) . | n (%) . | Events (events per 100 PY) . |
| Overall summary of TEAEs | ||||
| Any TEAEs | 134 (88.2) | 1069 (441.7) | 150 (95.5) | 1464 (558.4) |
| Any drug-related TEAEs | 15 (9.9) | 25 (10.3) | 8 (5.1) | 9 (3.4) |
| Any severe TEAEs | 52 (34.2) | 148 (61.2) | 75 (47.8) | 218 (83.1) |
| Any serious TEAEs | 80 (52.6) | 263 (108.7) | 115 (73.2) | 347 (132.3) |
| Any serious TEAE resulting in hospitalization | 77 (50.7) | 235 (97.1) | 113 (72.0) | 328 (125.1) |
| Any drug-related serious TEAEs | 2 (1.3) | 2 (0.8) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to trial treatment discontinuation | 6 (3.9) | 6 (2.5) | 5 (3.2) | 5 (1.9) |
| Any drug-related TEAEs leading to trial treatment discontinuation | 4 (2.6) | 4 (1.7) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to death | 16 (10.5) | 16 (6.6) | 19 (12.1) | 19 (7.2) |
| All deaths | 16 (10.5) | 16 (6.6) | 20 (12.7) | 20 (7.6) |
| TEAEs occurring in ≥10% of patients | ||||
| Infections | 84 (55.3) | 235 (97.1) | 109 (69.4) | 309 (117.8) |
| Peritonitis | 27 (17.8) | 34 (14.0) | 43 (27.4) | 53 (20.2) |
| Nasopharyngitis | 21 (13.8) | 28 (11.6) | 20 (12.7) | 29 (11.1) |
| Pneumonia | 18 (11.8) | 22 (9.1) | 17 (10.8) | 18 (6.9) |
| Gastrointestinal disorders | 61 (40.1) | 126 (52.1) | 74 (47.1) | 164 (62.5) |
| Metabolism and nutrition disorders | 56 (36.8) | 94 (38.8) | 79 (50.3) | 172 (65.6) |
| Hyperkalemia | 9 (5.9) | 10 (4.1) | 22 (14.0) | 26 (9.9) |
| Vascular disorders | 47 (30.9) | 70 (28.9) | 58 (36.9) | 94 (35.9) |
| Hypertension | 22 (14.5) | 25 (10.3) | 30 (19.1) | 33 (12.6) |
| General disorders and administration-site conditions | 58 (38.2) | 74 (30.6) | 44 (28.0) | 77 (29.4) |
| Asthenia | 16 (10.5) | 21 (8.7) | 7 (4.5) | 11 (4.2) |
| Nervous system disorders | 43 (28.3) | 63 (26.0) | 41 (26.1) | 64 (24.4) |
| Injury, poisoning, and procedural complications | 38 (25.0) | 77 (31.8) | 45 (28.7) | 88 (33.6) |
| Musculoskeletal and connective tissue disorders | 36 (23.7) | 48 (19.8) | 47 (29.9) | 75 (28.6) |
| Respiratory, thoracic, and mediastinal disorders | 32 (21.1) | 50 (20.7) | 42 (26.8) | 57 (21.7) |
| Cardiac disorders | 29 (19.1) | 60 (24.8) | 40 (25.5) | 76 (29.0) |
| Skin and subcutaneous tissue disorders | 21 (13.8) | 22 (9.1) | 31 (19.7) | 41 (15.6) |
| Blood and lymphatic system disorders | 15 (9.9) | 22 (9.1) | 25 (15.9) | 37 (14.1) |
| Psychiatric disorders | 14 (9.2) | 14 (5.8) | 23 (14.6) | 29 (11.1) |
| Eye disorders | 15 (9.9) | 18 (7.4) | 16 (10.2) | 24 (9.2) |
| . | Vadadustat (N = 152; exposure = 242.0 PY) . | Darbepoetin alfa (N = 157; exposure = 262.2 PY) . | ||
|---|---|---|---|---|
| Category . | n (%) . | Events (events per 100 PY) . | n (%) . | Events (events per 100 PY) . |
| Overall summary of TEAEs | ||||
| Any TEAEs | 134 (88.2) | 1069 (441.7) | 150 (95.5) | 1464 (558.4) |
| Any drug-related TEAEs | 15 (9.9) | 25 (10.3) | 8 (5.1) | 9 (3.4) |
| Any severe TEAEs | 52 (34.2) | 148 (61.2) | 75 (47.8) | 218 (83.1) |
| Any serious TEAEs | 80 (52.6) | 263 (108.7) | 115 (73.2) | 347 (132.3) |
| Any serious TEAE resulting in hospitalization | 77 (50.7) | 235 (97.1) | 113 (72.0) | 328 (125.1) |
| Any drug-related serious TEAEs | 2 (1.3) | 2 (0.8) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to trial treatment discontinuation | 6 (3.9) | 6 (2.5) | 5 (3.2) | 5 (1.9) |
| Any drug-related TEAEs leading to trial treatment discontinuation | 4 (2.6) | 4 (1.7) | 2 (1.3) | 2 (0.8) |
| Any TEAEs leading to death | 16 (10.5) | 16 (6.6) | 19 (12.1) | 19 (7.2) |
| All deaths | 16 (10.5) | 16 (6.6) | 20 (12.7) | 20 (7.6) |
| TEAEs occurring in ≥10% of patients | ||||
| Infections | 84 (55.3) | 235 (97.1) | 109 (69.4) | 309 (117.8) |
| Peritonitis | 27 (17.8) | 34 (14.0) | 43 (27.4) | 53 (20.2) |
| Nasopharyngitis | 21 (13.8) | 28 (11.6) | 20 (12.7) | 29 (11.1) |
| Pneumonia | 18 (11.8) | 22 (9.1) | 17 (10.8) | 18 (6.9) |
| Gastrointestinal disorders | 61 (40.1) | 126 (52.1) | 74 (47.1) | 164 (62.5) |
| Metabolism and nutrition disorders | 56 (36.8) | 94 (38.8) | 79 (50.3) | 172 (65.6) |
| Hyperkalemia | 9 (5.9) | 10 (4.1) | 22 (14.0) | 26 (9.9) |
| Vascular disorders | 47 (30.9) | 70 (28.9) | 58 (36.9) | 94 (35.9) |
| Hypertension | 22 (14.5) | 25 (10.3) | 30 (19.1) | 33 (12.6) |
| General disorders and administration-site conditions | 58 (38.2) | 74 (30.6) | 44 (28.0) | 77 (29.4) |
| Asthenia | 16 (10.5) | 21 (8.7) | 7 (4.5) | 11 (4.2) |
| Nervous system disorders | 43 (28.3) | 63 (26.0) | 41 (26.1) | 64 (24.4) |
| Injury, poisoning, and procedural complications | 38 (25.0) | 77 (31.8) | 45 (28.7) | 88 (33.6) |
| Musculoskeletal and connective tissue disorders | 36 (23.7) | 48 (19.8) | 47 (29.9) | 75 (28.6) |
| Respiratory, thoracic, and mediastinal disorders | 32 (21.1) | 50 (20.7) | 42 (26.8) | 57 (21.7) |
| Cardiac disorders | 29 (19.1) | 60 (24.8) | 40 (25.5) | 76 (29.0) |
| Skin and subcutaneous tissue disorders | 21 (13.8) | 22 (9.1) | 31 (19.7) | 41 (15.6) |
| Blood and lymphatic system disorders | 15 (9.9) | 22 (9.1) | 25 (15.9) | 37 (14.1) |
| Psychiatric disorders | 14 (9.2) | 14 (5.8) | 23 (14.6) | 29 (11.1) |
| Eye disorders | 15 (9.9) | 18 (7.4) | 16 (10.2) | 24 (9.2) |
PY, patient-years; SAEs, serious adverse events.
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