Summary of the ixazomib safety profile plus the most common (≥10% of patients overall) drug-related AEs, overall and within the dose-escalation and expansion cohorts
| AE, n (%) . | Dose-escalation cohorts (n = 26) . | Expansion cohorts (n = 40)* . | Total (n = 60) . |
|---|---|---|---|
| Any AE | 26 (100) | 40 (100) | 60 (100) |
| Any drug-related AE | 21 (81) | 38 (95) | 53 (88) |
| Any grade ≥3 AE | 19 (73) | 33 (83) | 47 (78) |
| Any drug-related grade ≥3 AE | 13 (50) | 27 (68) | 37 (62) |
| Any grade 4 AE | 7 (27) | 19 (48) | 23 (38) |
| Any drug-related grade 4 AE | 5 (19) | 13 (33) | 16 (27) |
| Any dose reduction due to AEs | 7 (27) | 21 (53) | 27 (45) |
| Any SAE† | 11 (42) | 24 (60) | 31 (52) |
| Common drug-related AEs | |||
| Nausea | 10 (38) | 18 (45) | 25 (42) |
| Thrombocytopenia | 9 (35) | 19 (48) | 25 (42) |
| Fatigue | 9 (35) | 16 (40) | 24 (40) |
| Skin and SC tissue disorders‡ | 11 (42) | 15 (38) | 24 (40) |
| Vomiting | 8 (31) | 8 (20) | 15 (25) |
| Diarrhea | 8 (31) | 8 (20) | 14 (23) |
| Pyrexia | 4 (15) | 8 (20) | 12 (20) |
| Neutropenia | 5 (19) | 7 (18) | 11 (18) |
| Peripheral neuropathy§ | 3 (12) | 5 (13) | 7 (12) |
| Chills | 2 (8) | 4 (10) | 6 (10) |
| AE, n (%) . | Dose-escalation cohorts (n = 26) . | Expansion cohorts (n = 40)* . | Total (n = 60) . |
|---|---|---|---|
| Any AE | 26 (100) | 40 (100) | 60 (100) |
| Any drug-related AE | 21 (81) | 38 (95) | 53 (88) |
| Any grade ≥3 AE | 19 (73) | 33 (83) | 47 (78) |
| Any drug-related grade ≥3 AE | 13 (50) | 27 (68) | 37 (62) |
| Any grade 4 AE | 7 (27) | 19 (48) | 23 (38) |
| Any drug-related grade 4 AE | 5 (19) | 13 (33) | 16 (27) |
| Any dose reduction due to AEs | 7 (27) | 21 (53) | 27 (45) |
| Any SAE† | 11 (42) | 24 (60) | 31 (52) |
| Common drug-related AEs | |||
| Nausea | 10 (38) | 18 (45) | 25 (42) |
| Thrombocytopenia | 9 (35) | 19 (48) | 25 (42) |
| Fatigue | 9 (35) | 16 (40) | 24 (40) |
| Skin and SC tissue disorders‡ | 11 (42) | 15 (38) | 24 (40) |
| Vomiting | 8 (31) | 8 (20) | 15 (25) |
| Diarrhea | 8 (31) | 8 (20) | 14 (23) |
| Pyrexia | 4 (15) | 8 (20) | 12 (20) |
| Neutropenia | 5 (19) | 7 (18) | 11 (18) |
| Peripheral neuropathy§ | 3 (12) | 5 (13) | 7 (12) |
| Chills | 2 (8) | 4 (10) | 6 (10) |
SC, subcutaneous.
Includes 6 patients treated at 2.0 mg/m2 in the dose-escalation cohorts.
Common drug-related SAEs included thrombocytopenia in 5 (8%) patients, pyrexia in 4 (7%), abdominal pain in 3 (5%), and dehydration and orthostatic hypotension each in 2 (3%); all other drug-related SAEs were reported in only 1 patient each.
MedDRA System Organ Class, includes rash macular (n = 11, 18%), rash (n = 6, 10%), erythema, rash maculo-papular, rash papular (each n = 4, 7%), pruritis (n = 3, 5%), dry skin, rash pruritic, skin exfoliation (each n = 2, 3%), erythema multiforme, hyperhidrosis, petechiae, photodermatosis, rash erythematous, skin discoloration, skin hyperpigmentation, skin lesion, swelling face, urticaria, and vasculitic rash (each n = 1, 2%). Patients could have reported >1 AE.
High-level term, peripheral neuropathies NEC includes neuropathy peripheral and peripheral sensory neuropathy.