Table 2.
Summary of Toxicities
| AE | No. (%) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Selinexor 30 mg/m2 (n = 19) | Selinexor 50 mg/m2 (n = 17) | Selinexor 60 mg (n = 18) | |||||||||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
| GI | |||||||||||||||
| Nausea* | 11 (57.9) | 3 (15.8) | 14 (73.7) | 8 (47.1) | 7 (41.2) | 1 (5.9) | 16 (94.1) | 7 (38.9) | 4 (22.2) | 11 (61.1) | |||||
| Dysgeusia | 8 (42.1) | 8 (42.1) | 4 (23.5) | 4 (23.5) | 8 (47.1) | 3 (16.7) | 3 (16.7) | ||||||||
| Vomiting* | 8 (42.1) | 1 (5.3) | 9 (47.4) | 7 (41.2) | 4 (23.5) | 1 (5.9) | 12 (70.6) | 4 (22.2) | 2 (11.1) | 6 (33.3) | |||||
| Anorexia* | 6 (31.6) | 2 (10.5) | 8 (42.1) | 3 (17.6) | 6 (35.3) | 1 (5.9) | 10 (58.8) | 1 (5.6) | 3 (16.7) | 4 (22.2) | |||||
| Diarrhea | 6 (31.6) | 1 (5.3) | 1 (5.3) | 8 (42.1) | 3 (17.6) | 1 (5.9) | 4 (23.5) | 1 (5.6) | 1 (5.6) | 1 (5.6) | 3 (16.7) | ||||
| Constitutional | |||||||||||||||
| Fatigue | 6 (31.6) | 8 (42.1) | 1 (5.3) | 15 (78.9) | 2 (11.8) | 7 (41.2) | 5 (29.4) | 14 (82.4) | 4 (22.2) | 5 (27.8) | 1 (5.6) | 10 (55.6) | |||
| Weight loss | 1 (5.3) | 2 (10.5) | 3 (15.8) | 5 (29.4) | 1 (5.9) | 6 (35.3) | 2 (11.1) | 2 (11.1) | 4 (22.2) | ||||||
| Blood | |||||||||||||||
| Platelet count decreased | 5 (26.3) | 3 (15.8) | 1 (5.3) | 1 (5.3) | 10 (52.6) | 3 (17.6) | 3 (17.6) | 2 (11.8) | 8 (47.1) | 4 (22.2) | 3 (16.7) | 1 (5.6) | 8 (44.4) | ||
| Anemia | 5 (26.3) | 1 (5.3) | 6 (31.6) | 4 (23.5) | 3 (17.6) | 3 (17.6) | 10 (58.8) | 4 (22.2) | 3 (16.7) | 1 (5.6) | 8 (44.4) | ||||
| WBC decreased | 2 (10.5) | 4 (21.1) | 2 (10.5) | 8 (42.1) | 1 (5.9) | 4 (23.5) | 1 (5.9) | 6 (35.3) | 1 (5.6) | 3 (16.7) | 1 (5.6) | 5 (27.8) | |||
| Neutrophil count decreased | 4 (21.1) | 2 (10.5) | 6 (31.6) | 2 (11.8) | 2 (11.8) | 1 (5.9) | 5 (29.4) | 1 (5.6) | 1 (5.6) | ||||||
| Lymphocyte count decreased | 4 (21.1) | 4 (21.1) | 1 (5.9) | 1 (5.9) | 1 (5.6) | 1 (5.6) | |||||||||
| Metabolic | |||||||||||||||
| Hyponatremia | 4 (21.1) | 2 (10.5) | 6 (31.6) | 5 (29.4) | 1 (5.9) | 6 (35.3) | 8 (44.4) | 8 (44.4) | |||||||
| Hypoalbuminemia | 3 (15.8) | 2 (10.5) | 5 (26.3) | 1 (5.9) | 1 (5.9) | 2 (11.1) | 1 (5.6) | 3 (16.7) | |||||||
| ALT increased | 3 (15.8) | 3 (15.8) | 1 (5.9) | 1 (5.9) | 1 (5.6) | 1 (5.6) | 2 (11.1) | ||||||||
| Other | |||||||||||||||
| Blurred vision | 3 (15.8) | 3 (15.8) | 8 (47.1) | 8 (47.1) | 2 (11.1) | 1 (5.6) | 3 (16.7) | ||||||||
| Dizziness*† | 1 (5.3) | 1 (5.3) | 2 (10.5) | 7 (41.2) | 2 (11.8) | 9 (52.9) | 1 (5.6) | 1 (5.6) | |||||||
NOTE. Treatment-related adverse events (AEs) occurring in at least 10% of the patient population (as a total sum of all grades) by selinexor dose (30 mg/m2, 50 mg/m2, or 60-mg flat dose). Grade 3 AEs occurring in fewer than 10% included: central autonomic dysfunction (n = 1), cataract (n = 1), urinary tract infection (n = 1), lipase increased (n = 2), serum amylase increased (n = 1), dehydration (n = 1), hypokalemia (n = 1), hypophosphatemia (n = 1), hematuria (n = 1), and maculopapular rash (n = 1). There were no unlisted grade 4 AEs related to selinexor treatment.
Indicates a significant difference between 60 mg and 50 mg/m2 for nausea (P = .03), vomiting (P = .04), and anorexia (P = .04).
Indicates a significant difference between 30 mg/m2 and 50 mg/m2 for dizziness (P = .01).