Table 2.
Incidence of TEAEs (Any Grade) Reported in >30% of Patients and Grade ≥3 TEAEs Reported in >5% of Patients
| TEAE, n (%) | Part A | Part B | Part C | Part B + Ca | ||||
|---|---|---|---|---|---|---|---|---|
| Marizomib (N = 30) |
Marizomib + Bevacizumab (N = 36) |
Marizomib + Bevacizumab (N = 41) |
Marizomib ≤0.8 mg/m2 + Bevacizumab (N = 67) |
|||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Fatigue | 20 (66.7) | 2 (6.7) | 25 (69.4) | 3 (8.3) | 33 (80.5) | 7 (17.1) | 49 (73.1) | 7 (10.4) |
| Nausea | 11 (36.7) | 2 (6.7) | 23 (63.9) | 0 | 20 (48.8) | 3 (7.3) | 36 (53.7) | 2 (3.0) |
| Hallucination | 13 (43.3) | 2 (6.7) | 13 (36.1) | 2 (5.6) | 26 (63.4) | 1 (2.4) | 32 (47.8) | 3 (4.5) |
| Confusion | 7 (23.3) | 0 | 10 (27.8) | 3 (8.3) | 24 (58.5) | 8 (19.5) | 27 (40.3) | 9 (13.4) |
| Vomiting | 10 (33.3) | 2 (6.7) | 19 (52.8) | 0 | 22 (53.7) | 2 (4.9) | 35 (52.2) | 1 (1.5) |
| Headache | 14 (46.7) | 1 (3.3) | 19 (52.8) | 5 (13.9) | 18 (43.9) | 3 (7.3) | 32 (47.8) | 7 (10.4) |
| Gait disturbance | 5 (16.7) | 0 | 5 (13.9) | 0 | 20 (48.8) | 1 (2.4) | 20 (29.9) | 0 |
| Hypertension | 4 (13.3) | 2 (6.7) | 16 (44.4) | 6 (16.7) | 11 (26.8) | 8 (19.5) | 24 (35.8) | 11 (16.4) |
| Insomnia | 13 (43.3) | 1 (3.3) | 4 (11.1) | 1 (2.8) | 11 (26.8) | 1 (2.4) | 13 (19.4) | 2 (3.0) |
| Ataxia | 8 (26.7) | 0 | 8 (22.2) | 1 (2.8) | 16 (39.0) | 7 (17.1) | 20 (29.9) | 5 (7.5) |
| Dizziness | 5 (16.7) | 0 | 10 (27.8) | 0 | 16 (39.0) | 1 (2.4) | 22 (32.8) | 1 (1.5) |
| Fall | 4 (13.3) | 0 | 10 (27.8) | 1 (2.8) | 15 (36.6) | 0 | 22 (32.8) | 0 |
| Muscular weakness | 6 (20.0) | 1 (3.3) | 7 (19.4) | 1 (2.8) | 15 (36.6) | 4 (9.8) | 19 (28.4) | 5 (7.5) |
| Constipation | 10 (33.3) | 0 | 9 (25.0) | 0 | 9 (22.0) | 0 | 15 (22.4) | 0 |
| Dysarthria | 7 (23.3) | 1 (3.3) | 6 (16.7) | 1 (2.8) | 13 (31.7) | 0 | 15 (22.4) | 0 |
| Dysphonia | 1 (3.3) | 0 | 11 (30.6) | 0 | 10 (24.4) | 0 | 20 (29.9) | 0 |
| Hyperglycemia | 8 (26.7) | 1 (3.3) | 8 (22.2) | 2 (5.6) | 8 (19.5) | 1 (2.4) | 15 (22.4) | 2 (5.6) |
| Aphasia | 7 (23.3) | 1 (3.3) | 6 (16.7) | 1 (2.8) | 9 (22.0) | 3 (7.3) | 12 (17.9) | 3 (4.5) |
| Convulsion | 5 (16.7) | 1 (3.3) | 7 (19.4) | 1 (2.8) | 9 (22.0) | 3 (7.3) | 13 (19.4) | 3 (4.5) |
| Hemiparesis | 5 (16.7) | 0 | 4 (11.1) | 3 (8.3) | 7 (17.1) | 2 (4.9) | 8 (11.9) | 5 (7.5) |
| Urinary tract infection | 1 (3.3) | 0 | 4 (11.1) | 0 | 7 (17.1) | 3 (7.3) | 11 (16.4) | 3 (4.5) |
| Decreased lymphocyte count | 5 (16.7) | 1 (3.3) | 3 (8.3) | 3 (8.3) | 3 (7.3) | 1 (2.4) | 6 (9.0) | 4 (6.0) |
| Proteinuria | 2 (6.7) | 0 | 4 (11.1) | 2 (5.6) | 4 (9.8) | 0 | 8 (11.9) | 2 (3.0) |
| Disease progression | 1 (3.3) | 1 (3.3) | 2 (5.6) | 2 (5.6) | 0 | 0 | 2 (3.0) | 2 (3.0) |
a Excluding dose-escalated patients.
TEAE, treatment-emergent adverse event.