Table 5.
Reported adverse events
| Adverse Events | BLIX cohort N=151 n (%) | Historical control cohort N=105 n (%) |
|---|---|---|
| Hypothyroidism | 41 (27.2) | 17 (16.2) |
| Gastrointestinal disturbances | 58 (38.4) | 100 (95.2) |
| Arthralgias | 25 (16.6) | 5(4.8) |
| Drug-induced liver injury | 6 (4.0) | 0 (0) |
| Cardiac changes | ||
| QTcFprolongationa | 49 (32.5) | - |
| Palpitations | 2 (1.3) | 0 (0) |
| Neurological changes | ||
| Peripheral neuropathy | 56 (37.1) | 1 (0.9) |
| Visual disturbances | 34 (22.5) | 16 (15.2) |
| Ototoxicity | 24 (15.9) | 61 (58.1) |
| Psychosis | 22 (14.6) | 6 (5.7) |
| Sleep disorders | 4 (2.6) | 0 (0) |
| Seizures | 4 (2.6) | 1 (0.9) |
| Hematological changes | ||
| Anemia | 38 (25.2) | 1 (0.9) |
| Leukopenia/neutropenia | 26 (17.2) | 0 (0) |
| Thrombocytopenia | 6 (4.0) | 0 (0) |
| Renal changes | ||
| Electrolyte abnormalities | 28 (18.5) | 35 (33.3) |
| Nephrotoxicity (unspecified) | 9 (6.0) | 6 (5.7) |
| Dermatological changes | ||
| Skin discoloration/Acne | 15 (9.9) | 2 (1.9) |
| Drug rash | 2 (1.3) | 13 (12.4) |
a
Seven of these patients had clinically relevant QTcF prolongation defined as any ECG-reported QTcF value >500 ms