Selinexor-related AEs
| AE . | No. (%) of patients . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Selinexor dose, mg/m2 . | All patients (n = 79) . | |||||||||||
| 3–23 (n = 14) . | 30–35 (n = 31) . | >35 (n = 34) . | ||||||||||
| Grade . | Total . | Grade . | Total . | Grade . | Total . | Grade . | Total . | |||||
| 1/2 . | 3/4 . | 1/2 . | 3/4 . | 1/2 . | 3/4 . | 1/2 . | 3/4 . | |||||
| Constitutional | ||||||||||||
| Fatigue | 5 (36) | 1 (7) | 6 (43) | 19 (61) | 6 (19) | 25 (81) | 15 (44) | 2 (6) | 17 (50) | 39 (49) | 9 (11) | 48 (61) |
| Weight loss | 2 (14) | 2 (14) | 7 (23) | 1 (3) | 8 (26) | 9 (26) | 1 (3) | 10 (29) | 18 (23) | 2 (3) | 20 (25) | |
| Gastrointestinal | ||||||||||||
| Nausea | 9 (64) | 9 (64) | 22 (71) | 22 (71) | 20 (59) | 1 (3) | 21 (62) | 51 (65) | 1 (1) | 52 (66) | ||
| Anorexia | 9 (64) | 9 (64) | 19 (61) | 19 (61) | 16 (47) | 1 (3) | 17 (50) | 44 (56) | 1 (1) | 45 (57) | ||
| Vomiting | 3 (21) | 3 (21) | 13 (42) | 13 (42) | 13 (38) | 13 (38) | 29 (37) | 29 (37) | ||||
| Diarrhea | 4 (29) | 4 (29) | 14 (45) | 1 (3) | 15 (48) | 7 (21) | 1 (3) | 8 (24) | 25 (32) | 2 (3) | 27 (34) | |
| Dysgeusia | 1 (7) | 1 (7) | 8 (26) | 8 (26) | 6 (18) | 6 (18) | 15 (19) | 15 (19) | ||||
| Constipation | 1 (7) | 1 (7) | 5 (16) | 5 (16) | 2 (6) | 2 (6) | 7 (9) | 1 (1) | 8 (10) | |||
| Hematologic | ||||||||||||
| Thrombocytopenia | 2 (14) | 5 (36) | 7 (50) | 3 (10) | 15 (48) | 18 (58) | 6 (18) | 17 (50) | 23 (68) | 11 (14) | 37 (47) | 48 (61) |
| Anemia | 5 (36) | 2 (14) | 7 (50) | 3 (10) | 9 (29) | 12 (39) | 4 (12) | 10 (29) | 14 (41) | 12 (15) | 21 (27) | 33 (39) |
| Neutropenia | 2 (14) | 3 (21) | 5 (36) | 2 (6) | 15 (48) | 17 (55) | 3 (9) | 7 (21) | 10 (29) | 7 (9) | 25 (32) | 32 (42) |
| Leukopenia | 2 (14) | 2 (14) | 7 (23) | 7 (23) | 1 (3) | 6 (18) | 7 (21) | 3 (4) | 13 (16) | 16 (20) | ||
| Metabolic | ||||||||||||
| Hyponatremia | 3 (21) | 1 (7) | 4 (29) | 6 (19) | 2 (6) | 8 (26) | 5 (15) | 5 (15) | 10 (29) | 14 (18) | 8 (10) | 22 (28) |
| Other | ||||||||||||
| Vision blurred | 1 (7) | 1 (7) | 10 (32) | 1 (3) | 11 (35) | 4 (12) | 1 (3) | 5 (15) | 15 (19) | 2 (3) | 17 (22) | |
| Dizziness | 1 (7) | 1 (7) | 4 (13) | 4 (13) | 8 (24) | 8 (24) | 13 (16) | 13 (16) | ||||
| Muscular weakness | 5 (16) | 1 (3) | 6 (19) | 3 (9) | 3 (9) | 8 (10) | 1 (1) | 9 (11) | ||||
| AE . | No. (%) of patients . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Selinexor dose, mg/m2 . | All patients (n = 79) . | |||||||||||
| 3–23 (n = 14) . | 30–35 (n = 31) . | >35 (n = 34) . | ||||||||||
| Grade . | Total . | Grade . | Total . | Grade . | Total . | Grade . | Total . | |||||
| 1/2 . | 3/4 . | 1/2 . | 3/4 . | 1/2 . | 3/4 . | 1/2 . | 3/4 . | |||||
| Constitutional | ||||||||||||
| Fatigue | 5 (36) | 1 (7) | 6 (43) | 19 (61) | 6 (19) | 25 (81) | 15 (44) | 2 (6) | 17 (50) | 39 (49) | 9 (11) | 48 (61) |
| Weight loss | 2 (14) | 2 (14) | 7 (23) | 1 (3) | 8 (26) | 9 (26) | 1 (3) | 10 (29) | 18 (23) | 2 (3) | 20 (25) | |
| Gastrointestinal | ||||||||||||
| Nausea | 9 (64) | 9 (64) | 22 (71) | 22 (71) | 20 (59) | 1 (3) | 21 (62) | 51 (65) | 1 (1) | 52 (66) | ||
| Anorexia | 9 (64) | 9 (64) | 19 (61) | 19 (61) | 16 (47) | 1 (3) | 17 (50) | 44 (56) | 1 (1) | 45 (57) | ||
| Vomiting | 3 (21) | 3 (21) | 13 (42) | 13 (42) | 13 (38) | 13 (38) | 29 (37) | 29 (37) | ||||
| Diarrhea | 4 (29) | 4 (29) | 14 (45) | 1 (3) | 15 (48) | 7 (21) | 1 (3) | 8 (24) | 25 (32) | 2 (3) | 27 (34) | |
| Dysgeusia | 1 (7) | 1 (7) | 8 (26) | 8 (26) | 6 (18) | 6 (18) | 15 (19) | 15 (19) | ||||
| Constipation | 1 (7) | 1 (7) | 5 (16) | 5 (16) | 2 (6) | 2 (6) | 7 (9) | 1 (1) | 8 (10) | |||
| Hematologic | ||||||||||||
| Thrombocytopenia | 2 (14) | 5 (36) | 7 (50) | 3 (10) | 15 (48) | 18 (58) | 6 (18) | 17 (50) | 23 (68) | 11 (14) | 37 (47) | 48 (61) |
| Anemia | 5 (36) | 2 (14) | 7 (50) | 3 (10) | 9 (29) | 12 (39) | 4 (12) | 10 (29) | 14 (41) | 12 (15) | 21 (27) | 33 (39) |
| Neutropenia | 2 (14) | 3 (21) | 5 (36) | 2 (6) | 15 (48) | 17 (55) | 3 (9) | 7 (21) | 10 (29) | 7 (9) | 25 (32) | 32 (42) |
| Leukopenia | 2 (14) | 2 (14) | 7 (23) | 7 (23) | 1 (3) | 6 (18) | 7 (21) | 3 (4) | 13 (16) | 16 (20) | ||
| Metabolic | ||||||||||||
| Hyponatremia | 3 (21) | 1 (7) | 4 (29) | 6 (19) | 2 (6) | 8 (26) | 5 (15) | 5 (15) | 10 (29) | 14 (18) | 8 (10) | 22 (28) |
| Other | ||||||||||||
| Vision blurred | 1 (7) | 1 (7) | 10 (32) | 1 (3) | 11 (35) | 4 (12) | 1 (3) | 5 (15) | 15 (19) | 2 (3) | 17 (22) | |
| Dizziness | 1 (7) | 1 (7) | 4 (13) | 4 (13) | 8 (24) | 8 (24) | 13 (16) | 13 (16) | ||||
| Muscular weakness | 5 (16) | 1 (3) | 6 (19) | 3 (9) | 3 (9) | 8 (10) | 1 (1) | 9 (11) | ||||
Treatment-related AEs for which at least 10% of all patients experienced (as a total sum of all grades) are listed by dose ranges as indicated. All other grade 3 and 4 AEs not listed (because the total AE % was <10%) included lymphopenia (n = 5); syncope (n = 4); cataract (n = 3); 2 each of alanine aminotransferase increased, confusion, dehydration, febrile neutropenia, hypocalcemia, and hypomagnesemia; and 1 each of ejection fraction decreased, encephalitis infection, gait disturbance, hypersomnia, hypokalemia, hypophosphatemia, hypotension, left ventricular systolic dysfunction, leukocytosis, serum amylase increase, and thrombotic thrombocytopenic purpura.