Table 3.
TEAEs and TRAEs (safety analysis set, n = 137)
| Preferred term, n (%) | TEAEs | TRAEs | ||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Patients with any AE | 137 (100) | 86 (63) | 134 (98) | 58 (42) |
| Hair color changes | 104 (76) | 0 | 104 (76) | 0 |
| Anemia | 81 (59) | 15 (11) | 67 (49) | 14 (10) |
| Elevated CPK | 80 (58) | 16 (12) | 77 (56) | 16 (12) |
| Fatigue | 76 (55) | 6 (4) | 60 (44) | 6 (4) |
| Vomiting | 68 (50) | 6 (4) | 28 (20) | 3 (2) |
| Hypophosphatemia | 64 (47) | 0 | 48 (35) | 0 |
| Headache | 61 (45) | 2 (1) | 29 (21) | 0 |
| Maculopapular rash | 60 (44) | 11 (8) | 56 (41) | 11 (8) |
| Pyrexia | 53 (39) | 5 (4) | 17 (12) | 1 (1) |
| Dry skin | 49 (36) | 0 | 45 (33) | 0 |
| Elevated LDH | 48 (35) | 0 | 42 (31) | 0 |
| Increased AST | 47 (34) | 4 (3) | 41 (30) | 4 (3) |
| Constipation | 45 (33) | 0 | 31 (23) | 0 |
| Nausea | 45 (33) | 0 | 25 (18) | 0 |
| Upper RTI | 43 (31) | 2 (1) | 2 (1) | 0 |
| Dermatitis acneiform | 42 (31) | 1 (1) | 41 (30) | 1 (1) |
| Epistaxis | 42 (31) | 1 (1) | 27 (20) | 0 |
| Decreased appetite | 39 (28) | 5 (4) | 28 (20) | 4 (3) |
| Paronychia | 36 (26) | 2 (1) | 32 (23) | 2 (1) |
| Pruritus | 35 (26) | 1 (1) | 32 (23) | 1 (1) |
| COVID-19 | 34 (25) | 0 | 0 | 0 |
| Weight decreased | 30 (22) | 2 (1) | 21 (15) | 0 |
| Cough | 30 (22) | 1 (1) | 2 (1) | 0 |
| Increased ALT | 29 (21) | 7 (5) | 24 (18) | 7 (5) |
| Hypokalemia | 29 (21) | 4 (3) | 15 (11) | 3 (2) |
| Diarrhea | 29 (21) | 2 (1) | 14 (10) | 1 (1) |
| Eczema | 25 (18) | 2 (1) | 22 (16) | 2 (1) |
| Hypocalcemia | 22 (16) | 2 (1) | 13 (9) | 1 (1) |
| Erythema | 20 (15) | 2 (1) | 18 (13) | 1 (1) |
| Photosensitivity reaction | 19 (14) | 1 (1) | 19 (14) | 1 (1) |
| Decreased growth velocity | 18 (13) | 7 (5) | 17 (12) | 7 (5) |
| Increased bilirubin | 18 (13) | 1 (1) | 16 (12) | 1 (1) |
| Hyponatremia | 17 (12) | 3 (2) | 4 (3) | 1 (1) |
| Erythematous rash | 14 (10) | 1 (1) | 14 (10) | 1 (1) |
| Decreased WBC count | 13 (9) | 2 (1) | 11 (8) | 1 (1) |
| Tumor hemorrhage | 12 (9) | 5 (4) | 10 (7) | 3 (2) |
| Decreased neutrophil count | 12 (9) | 4 (3) | 9 (7) | 3 (2) |
| Seizure | 11 (8) | 6 (4) | 1 (1) | 1 (1) |
| Weight increased | 10 (7) | 2 (1) | 6 (4) | 1 (1) |
| Lethargy | 9 (7) | 1 (1) | 6 (4) | 1 (1) |
| Pericardial effusion | 9 (7) | 1 (1) | 5 (4) | 1 (1) |
| Decreased phosphorus | 7 (5) | 1 (1) | 5 (4) | 1 (1) |
| Folliculitis | 5 (4) | 1 (1) | 4 (3) | 1 (1) |
| Prolonged APTT | 3 (2) | 1 (1) | 2 (1) | 1 (1) |
| Increased GGT | 3 (2) | 1 (1) | 1 (1) | 1 (1) |
| Systemic infection | 2 (1) | 2 (1) | 1 (1) | 1 (1) |
| Follicular rash | 2 (1) | 1 (1) | 2 (1) | 1 (1) |
| Optic nerve disorder | 2 (1) | 1 (1) | 1 (1) | 1 (1) |
| CSF circulation disorder | 1 (1) | 1 (1) | 1 (1) | 1 (1) |
| Cholecystitis | 1 (1) | 1 (1) | 1 (1) | 1 (1) |
| Eye infection viral | 1 (1) | 1 (1) | 1 (1) | 1 (1) |
| Pruritic rash | 1 (1) | 1 (1) | 1 (1) | 1 (1) |
TEAEs, TRAEs and laboratory abnormalities in ≥20% of patients and all TRAEs grade ≥3 occurring in ≥1 patient are reported. Patients are counted only once per event and are shown in the worst CTCAE grade that was reported for each event they experienced. MedDRA version 23.1; CTCAE version 5.0. APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; CSF, cerebrospinal fluid; GGT, gamma-glutamyl transferase; LDH, lactate dehydrogenase; RTI, respiratory tract infection; WBC, white blood cell.