AEs of all grades (by SOC and MedDRA preferred term) with a ≥ 10% difference in rate between the QW and BIW recommended dose cohorts, plus all grade ≥ 3 AEs reported in > 2 patients
| SOC/MedDRA preferred term . | Recommended dose groups . | Lower doses (N = 18) . | |
|---|---|---|---|
| 1.6 mg/m2 QW (N = 18) . | 1.3 mg/m2 BIW (N = 34) . | ||
| Blood and lymphatic system disorders | 3 (17) | 15 (44) | 4 (22) |
| Anemia | 2 (11) | 7 (21) | 2 (11) |
| Thrombocytopenia | 1 (6) | 8 (24) | 1 (6) |
| Cardiac disorders | 1 (6) | 10 (29) | 3 (17) |
| Gastrointestinal disorders | 17 (94) | 31 (91) | 13 (72) |
| Constipation | 8 (44) | 20 (59) | 5 (28) |
| Diarrhea | 14 (78) | 23 (68) | 9 (50) |
| Nausea | 15 (83) | 18 (53) | 9 (50) |
| Vomiting | 13 (72) | 13 (38) | 4 (22) |
| General disorders and administration site conditions | 15 (83) | 30 (88) | 15 (83) |
| Chills | 4 (22) | 3 (9) | 0 |
| Infections and infestations | 14 (78) | 18 (53) | 13 (72) |
| Upper respiratory tract infection | 5 (28) | 3 (9) | 2 (11) |
| Nervous system disorders | 15 (83) | 22 (65) | 13 (72) |
| Dizziness | 7 (39) | 9 (26) | 5 (28) |
| Peripheral neuropathy* | 4 (22) | 12 (35) | 1 (6) |
| Respiratory, thoracic, and mediastinal disorders | 8 (44) | 22 (65) | 8 (44) |
| Cough | 3 (17) | 12 (35) | 4 (22) |
| Skin and subcutaneous tissue disorders | 8 (44) | 19 (56) | 11 (61) |
| Pruritus | 4 (22) | 2 (6) | 3 (17) |
| Vascular disorders | 5 (28) | 16 (47) | 5 (28) |
| Orthostatic hypotension | 1 (6) | 7 (21) | 1 (6) |
| Grade ≥ 3 AEs reported in > 2 patients overall | |||
| Fatigue | 2 (11) | 6 (18) | 3 (17) |
| Thrombocytopenia | 0 | 6 (18) | 0 |
| Vomiting | 0 | 4 (12) | 0 |
| Diarrhea | 1 (6) | 2 (6) | 0 |
| Pneumonia | 1 (6) | 2 (6) | 0 |
| Syncope | 0 | 2 (6) | 1 (6) |
| SOC/MedDRA preferred term . | Recommended dose groups . | Lower doses (N = 18) . | |
|---|---|---|---|
| 1.6 mg/m2 QW (N = 18) . | 1.3 mg/m2 BIW (N = 34) . | ||
| Blood and lymphatic system disorders | 3 (17) | 15 (44) | 4 (22) |
| Anemia | 2 (11) | 7 (21) | 2 (11) |
| Thrombocytopenia | 1 (6) | 8 (24) | 1 (6) |
| Cardiac disorders | 1 (6) | 10 (29) | 3 (17) |
| Gastrointestinal disorders | 17 (94) | 31 (91) | 13 (72) |
| Constipation | 8 (44) | 20 (59) | 5 (28) |
| Diarrhea | 14 (78) | 23 (68) | 9 (50) |
| Nausea | 15 (83) | 18 (53) | 9 (50) |
| Vomiting | 13 (72) | 13 (38) | 4 (22) |
| General disorders and administration site conditions | 15 (83) | 30 (88) | 15 (83) |
| Chills | 4 (22) | 3 (9) | 0 |
| Infections and infestations | 14 (78) | 18 (53) | 13 (72) |
| Upper respiratory tract infection | 5 (28) | 3 (9) | 2 (11) |
| Nervous system disorders | 15 (83) | 22 (65) | 13 (72) |
| Dizziness | 7 (39) | 9 (26) | 5 (28) |
| Peripheral neuropathy* | 4 (22) | 12 (35) | 1 (6) |
| Respiratory, thoracic, and mediastinal disorders | 8 (44) | 22 (65) | 8 (44) |
| Cough | 3 (17) | 12 (35) | 4 (22) |
| Skin and subcutaneous tissue disorders | 8 (44) | 19 (56) | 11 (61) |
| Pruritus | 4 (22) | 2 (6) | 3 (17) |
| Vascular disorders | 5 (28) | 16 (47) | 5 (28) |
| Orthostatic hypotension | 1 (6) | 7 (21) | 1 (6) |
| Grade ≥ 3 AEs reported in > 2 patients overall | |||
| Fatigue | 2 (11) | 6 (18) | 3 (17) |
| Thrombocytopenia | 0 | 6 (18) | 0 |
| Vomiting | 0 | 4 (12) | 0 |
| Diarrhea | 1 (6) | 2 (6) | 0 |
| Pneumonia | 1 (6) | 2 (6) | 0 |
| Syncope | 0 | 2 (6) | 1 (6) |
SOC indicates system organ class; MedDRA, Medical Dictionary for Regulatory Activities; QW, once weekly; and BIW, twice weekly.
High-level term, including “neuropathy peripheral,” “peripheral motor neuropathy,” and “peripheral sensory neuropathy” preferred terms.