AEs related to selinexor administration
| AE . | No. of patients (%) . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16.8-23 mg/m2 . | 30-40 mg/m2 . | 55-75 mg/m2 . | Total . | |||||||||
| Grades 1-2 . | Grades 3-4 . | Total, n = 16 . | Grades 1-2 . | Grades 3-4 . | Total, n = 42 . | Grades 1-2 . | Grades 3-4 . | Total, n = 37 . | Grades 1-2 . | Grades 3-4 . | Total, n = 95 . | |
| Blood and lymphatic system disorders | ||||||||||||
| Anemia | 1 (6) | 1 (6) | 2 (13) | 2 (5) | 7 (17) | 9 (21) | 1 (3) | 8 (22) | 9 (24) | 4 (4) | 16 (17) | 20 (21) |
| Febrile neutropenia | — | — | — | — | 2 (5) | 2 (5) | — | 3 (8) | 3 (8) | — | 5 (5) | 5 (5) |
| Eye disorders | ||||||||||||
| Blurred vision | 2 (13) | — | 2 (13) | 6 (14) | — | 6 (14) | 7 (19) | — | 7 (19) | 15 (16) | — | 15 (16) |
| GI disorders | ||||||||||||
| Nausea | 11 (69) | 1 (6) | 12 (75) | 20 (48) | 1 (2) | 21 (50) | 16 (43) | 3 (8) | 19 (51) | 47 (49) | 5 (5) | 52 (55) |
| Diarrhea | 5 (31) | — | 5 (31) | 18 (43) | — | 18 (43) | 14 (38) | 1 (3) | 15 (41) | 37 (39) | 1 (1) | 38 (40) |
| Vomiting | 6 (38) | — | 6 (38) | 12 (29) | 2 (5) | 14 (33) | 13 (35) | 3 (8) | 16 (43) | 31 (33) | 5 (5) | 36 (38) |
| Mucositis oral | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 3 (8) | 1 (3) | 4 (11) | 8 (8) | 1 (1) | 9 (9) |
| Constipation | 1 (6) | — | 1 (6) | 3 (7) | — | 3 (7) | 3 (8) | 1 (3) | 4 (11) | 7 (7) | 1 (1) | 8 (8) |
| General disorders and administration site conditions | ||||||||||||
| Fatigue | 9 (56) | 2 (13) | 11 (69) | 18 (43) | 7 (17) | 25 (60) | 16 (43) | 4 (11) | 20 (54) | 43 (45) | 13 (14) | 56 (59) |
| Edema limbs | 3 (19) | — | 3 (19) | 2 (5) | — | 2 (5) | 1 (3) | — | 1 (3) | 6 (6) | — | 8 (8) |
| Investigations | ||||||||||||
| Weight loss | 8 (50) | — | 8 (50) | 8 (19) | 1 (2) | 9 (21) | 10 (27) | — | 10 (27) | 26 (27) | 1 (1) | 27 (28) |
| Platelet count decreased | — | 3 (19) | 3 (19) | — | 6 (14) | 6 (14) | — | 10 (27) | 10 (27) | — | 19 (20) | 19 (20) |
| Neutrophil count decreased | — | 3 (19) | 3 (19) | 1 (2) | 6 (14) | 7 (17) | — | 3 (8) | 3 (8) | 1 (1) | 12 (13) | 13 (14) |
| Creatinine increased | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 3 (8) | — | 3 (8) | 8 (8) | — | 8 (8) |
| Alanine aminotransferase increased | 2 (13) | — | 2 (13) | 1 (2) | 1 (2) | 2 (5) | 2 (5) | 1 (3) | 3 (8) | 5 (5) | 2 (2) | 7 (7) |
| Aspartate aminotransferase increased | 2 (13) | 1 (6) | 3 (19) | 2 (5) | — | 2 (5) | 2 (5) | — | 2 (5) | 6 (6) | 1 (1) | 7 (7) |
| WBC decreased | 1 (6) | 1 (6) | 2 (13) | — | 3 (7) | 3 (7) | — | 2 (5) | 2 (5) | 1 (1) | 6 (6) | 7 (7) |
| Lipase increased | — | — | — | 2 (5) | — | 2 (5) | — | 3 (8) | 3 (8) | 2 (2) | 3 (3) | 5 (5) |
| Serum amylase increased | — | — | — | 2 (5) | — | 2 (5) | 2 (5) | 1 (3) | 3 (8) | 4 (4) | 1 (1) | 5 (5) |
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 6 (38) | 2 (13) | 8 (50) | 20 (48) | 1 (2) | 21 (50) | 18 (49) | 5 (14) | 23 (62) | 44 (46) | 8 (8) | 52 (55) |
| Hyponatremia | 3 (19) | 1 (6) | 4 (25) | 7 (17) | 2 (5) | 9 (21) | 6 (16) | 2 (5) | 8 (22) | 16 (17) | 5 (5) | 21 (22) |
| Dehydration | 1 (6) | — | 1 (6) | 3 (7) | 4 (10) | 7 (17) | 5 (14) | 1 (3) | 6 (16) | 9 (9) | 5 (5) | 14 (15) |
| Hypokalemia | — | 2 (13) | 2 (13) | 2 (5) | — | 2 (5) | 6 (16) | 2 (5) | 8 (22) | 8 (8) | 4 (4) | 12 (13) |
| Hypomagnesemia | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 6 (16) | — | 6 (16) | 11 (12) | — | 11 (12) |
| Hyperglycemia | 1 (6) | — | 1 (6) | 4 (10) | 1 (2) | 5 (12) | 1 (3) | 1 (3) | 6 (16) | 6 (6) | 2 (2) | 8 (8) |
| Hypophosphatemia | — | — | — | 1 (2) | 1 (2) | 2 (5) | 2 (5) | 2 (5) | 4 (11) | 3 (3) | 3 (3) | 6 (6) |
| Hypoalbuminemia | 1 (6) | — | 1 (6) | 2 (5) | — | 2 (5) | 2 (5) | — | 2 (5) | 5 (5) | — | 5 (5) |
| Hypocalcemia | 1 (6) | — | 1 (6) | 1 (2) | — | 1 (2) | 2 (5) | 1 (3) | 3 (8) | 4 (4) | 1 (1) | 5 (5) |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Generalized muscle weakness | 2 (13) | 1 (6) | 3 (19) | 2 (5) | 1 (2) | 3 (7) | 3 (8) | 2 (5) | 5 (14) | 7 (7) | 4 (4) | 11 (12) |
| Nervous system disorders | ||||||||||||
| Dysgeusia | 2 (13) | — | 2 (13) | 12 (29) | — | 12 (29) | 5 (14) | — | 5 (14) | 19 (20) | — | 19 (20) |
| Dizziness | 3 (19) | — | 3 (19) | 1 (2) | — | 1 (2) | 7 (19) | — | 7 (19) | 11 (12) | — | 11 (12) |
| Headache | — | 1 (6) | 1 (6) | 2 (5) | — | 2 (5) | 3 (8) | 1 (3) | 4 (11) | 5 (5) | 2 (2) | 7 (7) |
| Respiratory, thoracic, and mediastinal disorders | ||||||||||||
| Epistaxis | 1 (6) | — | 1 (6) | — | 1 (2) | 1 (2) | 3 (8) | 1 (3) | 4 (11) | 4 (4) | 2 (2) | 6 (6) |
| Dyspnea | 3 (19) | — | 3 (19) | 1 (2) | 1 (2) | 2 (5) | — | — | — | 4 (4) | 1 (1) | 5 (5) |
| Vascular disorders | ||||||||||||
| Hypotension | 3 (19) | — | 3 (19) | — | — | — | 4 (11) | — | 4 (11) | 7 (7) | — | 7 (7) |
| AE . | No. of patients (%) . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 16.8-23 mg/m2 . | 30-40 mg/m2 . | 55-75 mg/m2 . | Total . | |||||||||
| Grades 1-2 . | Grades 3-4 . | Total, n = 16 . | Grades 1-2 . | Grades 3-4 . | Total, n = 42 . | Grades 1-2 . | Grades 3-4 . | Total, n = 37 . | Grades 1-2 . | Grades 3-4 . | Total, n = 95 . | |
| Blood and lymphatic system disorders | ||||||||||||
| Anemia | 1 (6) | 1 (6) | 2 (13) | 2 (5) | 7 (17) | 9 (21) | 1 (3) | 8 (22) | 9 (24) | 4 (4) | 16 (17) | 20 (21) |
| Febrile neutropenia | — | — | — | — | 2 (5) | 2 (5) | — | 3 (8) | 3 (8) | — | 5 (5) | 5 (5) |
| Eye disorders | ||||||||||||
| Blurred vision | 2 (13) | — | 2 (13) | 6 (14) | — | 6 (14) | 7 (19) | — | 7 (19) | 15 (16) | — | 15 (16) |
| GI disorders | ||||||||||||
| Nausea | 11 (69) | 1 (6) | 12 (75) | 20 (48) | 1 (2) | 21 (50) | 16 (43) | 3 (8) | 19 (51) | 47 (49) | 5 (5) | 52 (55) |
| Diarrhea | 5 (31) | — | 5 (31) | 18 (43) | — | 18 (43) | 14 (38) | 1 (3) | 15 (41) | 37 (39) | 1 (1) | 38 (40) |
| Vomiting | 6 (38) | — | 6 (38) | 12 (29) | 2 (5) | 14 (33) | 13 (35) | 3 (8) | 16 (43) | 31 (33) | 5 (5) | 36 (38) |
| Mucositis oral | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 3 (8) | 1 (3) | 4 (11) | 8 (8) | 1 (1) | 9 (9) |
| Constipation | 1 (6) | — | 1 (6) | 3 (7) | — | 3 (7) | 3 (8) | 1 (3) | 4 (11) | 7 (7) | 1 (1) | 8 (8) |
| General disorders and administration site conditions | ||||||||||||
| Fatigue | 9 (56) | 2 (13) | 11 (69) | 18 (43) | 7 (17) | 25 (60) | 16 (43) | 4 (11) | 20 (54) | 43 (45) | 13 (14) | 56 (59) |
| Edema limbs | 3 (19) | — | 3 (19) | 2 (5) | — | 2 (5) | 1 (3) | — | 1 (3) | 6 (6) | — | 8 (8) |
| Investigations | ||||||||||||
| Weight loss | 8 (50) | — | 8 (50) | 8 (19) | 1 (2) | 9 (21) | 10 (27) | — | 10 (27) | 26 (27) | 1 (1) | 27 (28) |
| Platelet count decreased | — | 3 (19) | 3 (19) | — | 6 (14) | 6 (14) | — | 10 (27) | 10 (27) | — | 19 (20) | 19 (20) |
| Neutrophil count decreased | — | 3 (19) | 3 (19) | 1 (2) | 6 (14) | 7 (17) | — | 3 (8) | 3 (8) | 1 (1) | 12 (13) | 13 (14) |
| Creatinine increased | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 3 (8) | — | 3 (8) | 8 (8) | — | 8 (8) |
| Alanine aminotransferase increased | 2 (13) | — | 2 (13) | 1 (2) | 1 (2) | 2 (5) | 2 (5) | 1 (3) | 3 (8) | 5 (5) | 2 (2) | 7 (7) |
| Aspartate aminotransferase increased | 2 (13) | 1 (6) | 3 (19) | 2 (5) | — | 2 (5) | 2 (5) | — | 2 (5) | 6 (6) | 1 (1) | 7 (7) |
| WBC decreased | 1 (6) | 1 (6) | 2 (13) | — | 3 (7) | 3 (7) | — | 2 (5) | 2 (5) | 1 (1) | 6 (6) | 7 (7) |
| Lipase increased | — | — | — | 2 (5) | — | 2 (5) | — | 3 (8) | 3 (8) | 2 (2) | 3 (3) | 5 (5) |
| Serum amylase increased | — | — | — | 2 (5) | — | 2 (5) | 2 (5) | 1 (3) | 3 (8) | 4 (4) | 1 (1) | 5 (5) |
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 6 (38) | 2 (13) | 8 (50) | 20 (48) | 1 (2) | 21 (50) | 18 (49) | 5 (14) | 23 (62) | 44 (46) | 8 (8) | 52 (55) |
| Hyponatremia | 3 (19) | 1 (6) | 4 (25) | 7 (17) | 2 (5) | 9 (21) | 6 (16) | 2 (5) | 8 (22) | 16 (17) | 5 (5) | 21 (22) |
| Dehydration | 1 (6) | — | 1 (6) | 3 (7) | 4 (10) | 7 (17) | 5 (14) | 1 (3) | 6 (16) | 9 (9) | 5 (5) | 14 (15) |
| Hypokalemia | — | 2 (13) | 2 (13) | 2 (5) | — | 2 (5) | 6 (16) | 2 (5) | 8 (22) | 8 (8) | 4 (4) | 12 (13) |
| Hypomagnesemia | 1 (6) | — | 1 (6) | 4 (10) | — | 4 (10) | 6 (16) | — | 6 (16) | 11 (12) | — | 11 (12) |
| Hyperglycemia | 1 (6) | — | 1 (6) | 4 (10) | 1 (2) | 5 (12) | 1 (3) | 1 (3) | 6 (16) | 6 (6) | 2 (2) | 8 (8) |
| Hypophosphatemia | — | — | — | 1 (2) | 1 (2) | 2 (5) | 2 (5) | 2 (5) | 4 (11) | 3 (3) | 3 (3) | 6 (6) |
| Hypoalbuminemia | 1 (6) | — | 1 (6) | 2 (5) | — | 2 (5) | 2 (5) | — | 2 (5) | 5 (5) | — | 5 (5) |
| Hypocalcemia | 1 (6) | — | 1 (6) | 1 (2) | — | 1 (2) | 2 (5) | 1 (3) | 3 (8) | 4 (4) | 1 (1) | 5 (5) |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Generalized muscle weakness | 2 (13) | 1 (6) | 3 (19) | 2 (5) | 1 (2) | 3 (7) | 3 (8) | 2 (5) | 5 (14) | 7 (7) | 4 (4) | 11 (12) |
| Nervous system disorders | ||||||||||||
| Dysgeusia | 2 (13) | — | 2 (13) | 12 (29) | — | 12 (29) | 5 (14) | — | 5 (14) | 19 (20) | — | 19 (20) |
| Dizziness | 3 (19) | — | 3 (19) | 1 (2) | — | 1 (2) | 7 (19) | — | 7 (19) | 11 (12) | — | 11 (12) |
| Headache | — | 1 (6) | 1 (6) | 2 (5) | — | 2 (5) | 3 (8) | 1 (3) | 4 (11) | 5 (5) | 2 (2) | 7 (7) |
| Respiratory, thoracic, and mediastinal disorders | ||||||||||||
| Epistaxis | 1 (6) | — | 1 (6) | — | 1 (2) | 1 (2) | 3 (8) | 1 (3) | 4 (11) | 4 (4) | 2 (2) | 6 (6) |
| Dyspnea | 3 (19) | — | 3 (19) | 1 (2) | 1 (2) | 2 (5) | — | — | — | 4 (4) | 1 (1) | 5 (5) |
| Vascular disorders | ||||||||||||
| Hypotension | 3 (19) | — | 3 (19) | — | — | — | 4 (11) | — | 4 (11) | 7 (7) | — | 7 (7) |
AEs observed in at least 5% of all enrolled patients at any point while on study are listed as number of patients (%). Unlisted grade 4 AEs occurring in <5% of the patient population include lymphocyte count decreased (1), pneumonitis (1), sepsis (1), and blood in stool (1).
—, No reported incidents.