Table 3.
TEAEs for conditions with more than 15 events in the total population
| Cohort | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 14.1 | 15 | All |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients reporting ≥1 TEAE | 4 (100) [20] | 3 (100) [42] | 3 (100) [41] | 3 (100) [32] | 3 (100) [32] | 5 (100) [91] | 3 (100) [52] | 6 (100) [85] | 3 (100) [26] | 4 (100) [53] | 4 (100) [22] | 6 (100) [109] | 6 (100) [183] | 6 (100) [153] | 6 (100) [158] | 4 (100) [58] | 69 (100) [1157] |
| Nausea | |||||||||||||||||
| All grades | 0 | 3 (100) [3] | 2 (67) [2] | 0 | 1 (33)[3] | 4 (80) [7] | 3 (100) [4] | 4 (67) [11] | 1 (33) [1] | 4 (100) [6] | 1 (25) [1] | 4 (67) [9] | 4 (67) [11] | 5 (83) [12] | 5 (83) [14] | 3 (75) [3] | 44 (64) [87] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) [1] | 1 (17) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 2 (50) [2] | 5 (7) [5] |
| Vomiting | |||||||||||||||||
| All grades | 0 | 1 (33) [1] | 0 | 0 | 0 | 2 (40) [4] | 1 (33) [1] | 4 (67) [7] | 1 (33) [1] | 4 (100) [6] | 0 | 4 (67) [8] | 3 (50) [10] | 5 (83) [15] | 4 (67) [12] | 3 (75) [3] | 32 (46) [68] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 2 (3) [2] |
| Diarrhea | |||||||||||||||||
| All grades | 2 (50) [2] | 2 (67) [2] | 1 (33) [1] | 1 (33) [2] | 1 (33) [1] | 0 | 1 (33) [3] | 2 (33) [3] | 3 (100) [6] | 2 (50) [4] | 0 | 2 (33) [3] | 3 (50) [6] | 1 (17) [4] | 3 (50) [7] | 1 (25) [1] | 25 (36) [45] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Infusion-related reaction | |||||||||||||||||
| All grades | 0 | 0 | 1 (33) [1] | 0 | 2 (67) [2] | 1 (20) [2] | 1 (33) [1] | 4 (67) [8] | 2 (67) [5] | 1 (25) [4] | 1 (25) [1] | 4 (67) [8] | 3 (50) [4] | 0 | 0 | 0 | 20 (29) [36] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | |||||||||||||||||
| All grades | 0 | 1 (33) [1] | 0 | 0 | 0 | 1(20) [1] | 0 | 0 | 0 | 0 | 1 (25) [2] | 1 (17) [1] | 2 (33) [7] | 4 (67) [12] | 4 (67) [5] | 3 (75) [4] | 17 (25) [33] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 1 (1) [1] |
| Decreased appetite | |||||||||||||||||
| All grades | 0 | 1 (33) [1] | 1 (33) [1] | 0 | 0 | 0 | 1 (33) [1] | 0 | 1 (33) [1] | 0 | 1 (25) [1] | 3 (50) [8] | 3 (50) [6] | 2 (33) [8] | 2 (33) [3] | 0 | 15 (22) [30] |
| Grade ≥ 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypokalemia | |||||||||||||||||
| All grades | 0 | 2 (67) [2] | 0 | 0 | 1 (33) [1] | 2 (40) [5] | 2 (67) [3] | 4 (67) [10] | 0 | 1 (25) [1] | 0 | 0 | 3 (50) [4] | 0 | 2 (33) [3] | 1 (25) [1] | 18 (26) [30] |
| Grade ≥3 | 0 | 1 (33) [1] | 0 | 0 | 0 | 1 (20) [2] | 1 (33) [1] | 1 (17) [3] | 0 | 0 | 0 | 0 | 1 (17) [2] | 0 | 0 | 0 | 5 (7) [10] |
| Pyrexia | |||||||||||||||||
| All grades | 0 | 1 (33) [2] | 2 (67) [3] | 1 (33) [3] | 0 | 1 (20) [1] | 0 | 0 | 1 (33) [1] | 1 (25) [1] | 1 (25) [1] | 3 (50) [4] | 2 (33) [3] | 2 (33) [3] | 2 (33) [5] | 0 | 17 (25) [27] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [1] | 0 | 0 | 2 (3) [2] |
| Alanine aminotransferase increased | 0 | 0 | 0 | 0 | 2 (67) [3] | 3 (60) [8] | 0 | 1 (17) [1] | 0 | 0 | 0 | 1 (17) [1] | 1 (17) [2] | 0 | 2 (33) [6] | 1 (25) [1] | 11 (16) [22] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asthenia | |||||||||||||||||
| All grades | 0 | 0 | 0 | 1 (33) [1] | 0 | 0 | 0 | 0 | 1 (33) [1] | 0 | 0 | 1 (17) [1] | 4 (67) [7] | 3 (50) [6] | 4 (67) [5] | 1 (25) [1] | 15 (22) [22] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 1 (1) [1] |
| Chills | |||||||||||||||||
| All grades | 0 | 0 | 1 (33) [1] | 0 | 0 | 1 (20) [1] | 1 (33) [1] | 1 (17) [1] | 0 | 0 | 0 | 2 (33) [2] | 0 | 0 | 2 (33) [16] | 0 | 8 (12) [22] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache | |||||||||||||||||
| All grades | 1 (25) [1] | 1 (33) [2] | 1 (33) [1] | 1 (33) [1] | 0 | 0 | 0 | 2 (33) [2] | 0 | 0 | 1 (25) [1] | 0 | 2 (33) [2] | 2 (33) [3] | 3 (50) [7] | 0 | 14 (20) [20] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 1 (25) [1] | 0 | 0 | 0 | 1 (17) [1] | 0 | 3 (4) [3] |
| Dizziness | |||||||||||||||||
| All grades | 3 (75) [3] | 1 (33) [1] | 0 | 1 (33) [1] | 1 (33) [1] | 0 | 2 (67) [2] | 3 (50) [5] | 1 (33) [1] | 0 | 0 | 0 | 2 (33) [2] | 2 (33) [2] | 1 (17) [1] | 0 | 17 (25) [19] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatigue | |||||||||||||||||
| All grades | 2 (50) [2] | 3 (100) [3] | 2 (67) [2] | 1 (33) [1] | 0 | 0 | 1 (33) [2] | 2 (33) [2] | 2 (67) [2] | 0 | 0 | 2 (33) [2] | 0 | 0 | 1 (17) [1] | 0 | 16 (23) [17] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) [1] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) [1] |
| Hypophosphatemia | |||||||||||||||||
| All grades | 0 | 0 | 0 | 0 | 0 | 3 (60) [3] | 1 (33) [1] | 2 (33) [4] | 0 | 0 | 1 (25) [3] | 1 (17) [1] | 2 (33) [4] | 1 (17) [1] | 0 | 0 | 11 (16) [17] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 1 (20) [1] | 1 (33) [1] | 0 | 0 | 0 | 1 (25) [1] | 1 (17) [1] | 2 (33) [2] | 0 | 0 | 0 | 6 (8) [7] |
| Constipation | |||||||||||||||||
| All grades | 0 | 0 | 0 | 0 | 1 (33) [1] | 0 | 1 (33) [1] | 2 (33) [2] | 0 | 1 (25) [2] | 0 | 1 (17) [1] | 3 (50) [4] | 1 (17) [1] | 2 (33) [2] | 1 (25) [1] | 13 (19) [15] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) [1] | 1 (1) [1] |
| Dyspnea | |||||||||||||||||
| All grades | 0 | 0 | 1 (33) [1] | 1 (33) [1] | 1 (33) [1] | 1 (20) [1] | 2 (67) [2] | 0 | 0 | 0 | 0 | 1 (17) [2] | 2 (33) [2] | 1 (17) [1] | 3 (50) [3] | 1 (25) [1] | 14 (20) [15] |
| Grade ≥3 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (67) [2] | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3) [2] |
Data are presented as number of patients reporting TEAEs (percentage of patients reporting TEAEs) [number of TEAEs].