AEs
| AE . | Dose level . | All patients (N = 45) . | ||||||
|---|---|---|---|---|---|---|---|---|
| 2 × 106 (n = 6) . | 1 × 106 (n = 23) . | 0.5 × 106 (n = 16) . | ||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any AE | 6 (100) | 6 (100) | 23 (100) | 23 (100) | 16 (100) | 15 (94) | 45 (100) | 44 (98) |
| Pyrexia | 6 (100) | 3 (50) | 22 (96) | 11 (48) | 12 (75) | 5 (31) | 40 (89) | 19 (42) |
| Hypotension | 5 (83) | 3 (50) | 17 (74) | 11 (48) | 9 (56) | 4 (25) | 31 (69) | 18 (40) |
| Chills | 3 (50) | 0 | 13 (57) | 0 | 3 (19) | 0 | 19 (42) | 0 |
| Diarrhea | 3 (50) | 0 | 10 (43) | 1 (4) | 6 (38) | 0 | 19 (42) | 1 (2) |
| Headache | 1 (17) | 0 | 10 (43) | 1 (4) | 7 (44) | 1 (6) | 18 (40) | 2 (4) |
| Anemia | 4 (67) | 4 (67) | 10 (43) | 8 (35) | 3 (19) | 2 (13) | 17 (38) | 14 (31) |
| Encephalopathy | 4 (67) | 2 (33) | 11 (48) | 6 (26) | 2 (13) | 2 (13) | 17 (38) | 10 (22) |
| Hypophosphatemia | 2 (33) | 1 (17) | 12 (52) | 10 (43) | 3 (19) | 3 (19) | 17 (38) | 14 (31) |
| Nausea | 1 (17) | 0 | 13 (57) | 1 (4) | 3 (19) | 0 | 17 (38) | 1 (2) |
| Confusional state | 2 (33) | 1 (17) | 9 (39) | 1 (4) | 5 (31) | 2 (13) | 16 (36) | 4 (9) |
| Hypoxia | 2 (33) | 1 (17) | 8 (35) | 6 (26) | 6 (38) | 4 (25) | 16 (36) | 11 (24) |
| Decreased platelet count | 3 (50) | 3 (50) | 8 (35) | 8 (35) | 5 (31) | 4 (25) | 16 (36) | 15 (33) |
| Constipation | 2 (33) | 0 | 10 (43) | 0 | 2 (13) | 0 | 14 (31) | 0 |
| Fatigue | 1 (17) | 0 | 7 (30) | 1 (4) | 6 (38) | 0 | 14 (31) | 1 (2) |
| Sinus tachycardia | 2 (33) | 0 | 10 (43) | 1 (4) | 2 (13) | 0 | 14 (31) | 1 (2) |
| Hypokalemia | 1 (17) | 0 | 11 (48) | 0 | 1 (6) | 0 | 13 (29) | 0 |
| Tachycardia | 1 (17) | 1 (17) | 6 (26) | 1 (4) | 6 (38) | 0 | 13 (29) | 2 (4) |
| Tremor | 1 (17) | 0 | 8 (35) | 0 | 4 (25) | 0 | 13 (29) | 0 |
| Decreased appetite | 0 | 0 | 9 (39) | 2 (9) | 3 (19) | 0 | 12 (27) | 2 (4) |
| Hyperglycemia | 1 (17) | 0 | 6 (26) | 0 | 5 (31) | 1 (6) | 12 (27) | 1 (2) |
| Hypomagnesemia | 2 (33) | 0 | 8 (35) | 0 | 2 (13) | 0 | 12 (27) | 0 |
| Hyponatremia | 3 (50) | 2 (33) | 7 (30) | 3 (13) | 2 (13) | 0 | 12 (27) | 5 (11) |
| Peripheral edema | 1 (17) | 0 | 7 (30) | 1 (4) | 4 (25) | 0 | 12 (27) | 1 (2) |
| AE . | Dose level . | All patients (N = 45) . | ||||||
|---|---|---|---|---|---|---|---|---|
| 2 × 106 (n = 6) . | 1 × 106 (n = 23) . | 0.5 × 106 (n = 16) . | ||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any AE | 6 (100) | 6 (100) | 23 (100) | 23 (100) | 16 (100) | 15 (94) | 45 (100) | 44 (98) |
| Pyrexia | 6 (100) | 3 (50) | 22 (96) | 11 (48) | 12 (75) | 5 (31) | 40 (89) | 19 (42) |
| Hypotension | 5 (83) | 3 (50) | 17 (74) | 11 (48) | 9 (56) | 4 (25) | 31 (69) | 18 (40) |
| Chills | 3 (50) | 0 | 13 (57) | 0 | 3 (19) | 0 | 19 (42) | 0 |
| Diarrhea | 3 (50) | 0 | 10 (43) | 1 (4) | 6 (38) | 0 | 19 (42) | 1 (2) |
| Headache | 1 (17) | 0 | 10 (43) | 1 (4) | 7 (44) | 1 (6) | 18 (40) | 2 (4) |
| Anemia | 4 (67) | 4 (67) | 10 (43) | 8 (35) | 3 (19) | 2 (13) | 17 (38) | 14 (31) |
| Encephalopathy | 4 (67) | 2 (33) | 11 (48) | 6 (26) | 2 (13) | 2 (13) | 17 (38) | 10 (22) |
| Hypophosphatemia | 2 (33) | 1 (17) | 12 (52) | 10 (43) | 3 (19) | 3 (19) | 17 (38) | 14 (31) |
| Nausea | 1 (17) | 0 | 13 (57) | 1 (4) | 3 (19) | 0 | 17 (38) | 1 (2) |
| Confusional state | 2 (33) | 1 (17) | 9 (39) | 1 (4) | 5 (31) | 2 (13) | 16 (36) | 4 (9) |
| Hypoxia | 2 (33) | 1 (17) | 8 (35) | 6 (26) | 6 (38) | 4 (25) | 16 (36) | 11 (24) |
| Decreased platelet count | 3 (50) | 3 (50) | 8 (35) | 8 (35) | 5 (31) | 4 (25) | 16 (36) | 15 (33) |
| Constipation | 2 (33) | 0 | 10 (43) | 0 | 2 (13) | 0 | 14 (31) | 0 |
| Fatigue | 1 (17) | 0 | 7 (30) | 1 (4) | 6 (38) | 0 | 14 (31) | 1 (2) |
| Sinus tachycardia | 2 (33) | 0 | 10 (43) | 1 (4) | 2 (13) | 0 | 14 (31) | 1 (2) |
| Hypokalemia | 1 (17) | 0 | 11 (48) | 0 | 1 (6) | 0 | 13 (29) | 0 |
| Tachycardia | 1 (17) | 1 (17) | 6 (26) | 1 (4) | 6 (38) | 0 | 13 (29) | 2 (4) |
| Tremor | 1 (17) | 0 | 8 (35) | 0 | 4 (25) | 0 | 13 (29) | 0 |
| Decreased appetite | 0 | 0 | 9 (39) | 2 (9) | 3 (19) | 0 | 12 (27) | 2 (4) |
| Hyperglycemia | 1 (17) | 0 | 6 (26) | 0 | 5 (31) | 1 (6) | 12 (27) | 1 (2) |
| Hypomagnesemia | 2 (33) | 0 | 8 (35) | 0 | 2 (13) | 0 | 12 (27) | 0 |
| Hyponatremia | 3 (50) | 2 (33) | 7 (30) | 3 (13) | 2 (13) | 0 | 12 (27) | 5 (11) |
| Peripheral edema | 1 (17) | 0 | 7 (30) | 1 (4) | 4 (25) | 0 | 12 (27) | 1 (2) |
Data are presented as n (%). Table includes AEs of any grade occurring in ≥25% of all patients.