Table 2.
Adverse events related to study drug occurring in ≥6 (10%) of patients overall.
| MedDRA preferred term | DCDS0780A <2.4 mg/kg monotherapy (n = 11) | DCDS0780A ≥2.4 mg/kg monotherapy (n = 40) | DCDS0780A ≥3.6 mg/kg + rituximab (n = 9) | Total (N = 60) |
|---|---|---|---|---|
| Patients with ≥1 AE, n (%) | 9 | 37 | 8 (89) | 54 (90) |
| Total number of events | 38 | 193 | 45 | 276 |
| Vision blurred | 0 | 16 (40) | 5 (56) | 21 (35) |
| Corneal deposits | 1 (9) | 14 (35) | 2 (22) | 17 (28) |
| Fatigue | 2 (18) | 14 (35) | 1 (11) | 17 (28) |
| Neutropenia | 2 (18) | 14 (35) | 0 | 16 (27) |
| Nausea | 2 (18) | 9 (23) | 1 (11) | 12 (20) |
| Neuropathy peripheral | 1 (9) | 8 (20) | 3 (33) | 12 (20) |
| Diarrhea | 0 | 9 (23) | 2 (22) | 11 (18) |
| Peripheral sensory neuropathy | 2 (18) | 5 (13) | 1 (11) | 8 (13) |
| Decreased appetite | 1 (9) | 4 (10) | 1 (11) | 6 (10) |
| Keratitis | 0 | 3 (8) | 3 (33) | 6 (10) |