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Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer

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ClinicalTrials.gov Identifier: NCT01607892
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematological Malignancies
Intervention Drug: KPT-330
Enrollment 286
Recruitment Details The study was conducted at 12 sites in United States, Canada and Europe between 23 July 2012 (first participant treated) and 13 October 2015 (last participant completed).
Pre-assignment Details A total of 286 participants were enrolled out of which 1 participants with MM never treated due to disease progression prior to dose initiation and 285 participants received treatment in 11 different schedules. The schedules were either 28 days (Schedules 1-7, 9-11) or 21 days (Schedule 8) per cycle and participants were treated once weekly (Schedule 7), twice weekly (Schedules 3-6, 8-11) or three times weekly alternating with 2 times weekly (Schedules 1, 2).
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses. Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses. Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Period Title: Overall Study
Started 58 27 81 95 24
Completed 0 0 0 0 0
Not Completed 58 27 81 95 24
Reason Not Completed
Need of treatment not allowed per protocol             0             0             0             1             0
Death             4             2             8             10             3
Investigator discretion             2             4             4             8             0
Other treatments became available             1             1             0             0             2
Intercurrent illness             1             0             0             3             0
Non-Compliance with study procedures             0             0             1             0             0
Consent withdrawn by participant             9             4             24             14             4
Disease progression             38             13             37             57             9
Incidence or severity of Adverse events             3             3             7             2             6
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL) Total
Hide Arm/Group Description Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses. Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses. Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses. Total of all reporting groups
Overall Number of Baseline Participants 58 27 81 95 24 285
Hide Baseline Analysis Population Description
Safety population consisted of all participants who received at least 1 dose of selinexor.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 27 participants 81 participants 95 participants 24 participants 285 participants
57.8  (14.00) 58.0  (15.90) 62.1  (8.76) 65.6  (15.33) 60.9  (15.23) 61.9  (13.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 27 participants 81 participants 95 participants 24 participants 285 participants
Female
28
  48.3%
9
  33.3%
38
  46.9%
40
  42.1%
8
  33.3%
123
  43.2%
Male
30
  51.7%
18
  66.7%
43
  53.1%
55
  57.9%
16
  66.7%
162
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 27 participants 81 participants 95 participants 24 participants 285 participants
Hispanic or Latino
2
   3.4%
1
   3.7%
4
   4.9%
2
   2.1%
0
   0.0%
9
   3.2%
Not Hispanic or Latino
52
  89.7%
23
  85.2%
72
  88.9%
88
  92.6%
23
  95.8%
258
  90.5%
Unknown or Not Reported
4
   6.9%
3
  11.1%
5
   6.2%
5
   5.3%
1
   4.2%
18
   6.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 27 participants 81 participants 95 participants 24 participants 285 participants
White
52
  89.7%
20
  74.1%
65
  80.2%
88
  92.6%
23
  95.8%
248
  87.0%
Black
2
   3.4%
3
  11.1%
11
  13.6%
5
   5.3%
1
   4.2%
22
   7.7%
Asian
0
   0.0%
1
   3.7%
4
   4.9%
1
   1.1%
1
   4.2%
7
   2.5%
Native Hawaiian or Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
American Indian or Alaskan Native
0
   0.0%
1
   3.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Other
0
   0.0%
2
   7.4%
1
   1.2%
0
   0.0%
0
   0.0%
3
   1.1%
Unknown/Not Reported
4
   6.9%
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
5
   1.8%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.
Time Frame From first dose of study drug administration to end of treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all participants who received at least 1 dose of selinexor.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 58 27 81 95 24
Measure Type: Count of Participants
Unit of Measure: Participants
At Least One TEAE
58
 100.0%
27
 100.0%
81
 100.0%
95
 100.0%
24
 100.0%
At Least One Serious TEAE
33
  56.9%
7
  25.9%
52
  64.2%
73
  76.8%
13
  54.2%
2.Primary Outcome
Title Recommended Phase 2 Dose (RP2D) of Selinexor
Hide Description Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which > 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was >25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.
Time Frame From first dose of study drug administration to end of treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure.
Arm/Group Title Advanced Hematological Malignancies.
Hide Arm/Group Description:
Participants received selinexor doses of <= 12 mg/m^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; >12 mg/m^2 3 times weekly for Weeks 2 and 4 in schedule 2; >=30 mg/m^2 on Day 1 and 3 in schedule 3; >= 23 mg/m^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; >= 30 mg/m^2 on Day 1 and 4 in schedule 5; >= 35 mg/m^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; >= 45 mg/m^2 once-weekly in schedule 7; >= 40 mg/m^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; >= 30 mg/m^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m^2 Rituximab in schedule 9; 55 mg/m^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 285
Measure Type: Number
Unit of Measure: milligram per square meter (mg/m^2)
35
3.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Selinexor
Hide Description Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 3 6 13 18 21 13 8 9 8 4 8 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
49.0 [1] 
(NA%)
50.0
(61.1%)
149
(37.6%)
205
(46.8%)
262
(37.5%)
387
(37.1%)
407
(44.4%)
416
(36.6%)
670
(18.5%)
583
(41.4%)
668
(33.2%)
800
(32.4%)
1068
(49.3%)
[1]
Geometric coefficient of variation (CV) was not calculated as data were available for only two participants.
4.Secondary Outcome
Title Time to Maximum Observed Concentration (Tmax) of Selinexor
Hide Description Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 3 6 13 18 21 13 8 9 8 4 8 5
Median (Full Range)
Unit of Measure: hour
NA [1] 
(2.1 to 2.2)
4.0
(2.1 to 7.7)
3.0
(1.1 to 4.2)
2.08
(0.92 to 8.5)
2.0
(1.0 to 7.8)
2.0
(0.72 to 4.4)
2.0
(0.92 to 4.1)
4.0
(2.0 to 7.5)
2.0
(0.50 to 4.2)
2.9
(1.0 to 8.0)
1.9
(1.8 to 2.0)
2.0
(1.0 to 4.0)
2.0
(0.5 to 4.0)
[1]
Median value was not calculated due to insufficient PK samples required for calculation.
5.Secondary Outcome
Title Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor
Hide Description Cavg0-24h was defined as average concentration from time 0 to 24 hours.
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 3 6 12 17 19 13 8 9 6 3 4 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
17.0 [1] 
(NA%)
20.3
(94.8%)
61.8
(39.9%)
79.0
(61.8%)
108
(46.8%)
160
(38.0%)
168
(54.0%)
163
(29.2%)
297
(26.3%)
208
(19.1%)
337
(4.2%)
353
(26.2%)
NA [2] 
(NA%)
[1]
Geometric CV was not calculated as data were available for only two participants.
[2]
Geometric mean and CV were not calculated as data were available for only one participant.
6.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor
Hide Description AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 3 6 13 18 21 13 8 9 8 4 8 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram* hours per milliliter
331 [1] 
(NA%)
564
(41.9%)
1459
(20.5%)
1829
(23.3%)
2774
(36.7%)
3461
(26.9%)
3901
(29.2%)
4481
(23.8%)
5228
(21.6%)
5601
(36.2%)
5282
(57.9%)
5466
(45.7%)
5544
(33.2%)
[1]
Geometric CV was not calculated as data were available for only two participants.
7.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor
Hide Description AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 2 6 12 12 21 13 8 9 7 3 4 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
348 [1] 
(NA%)
733 [1] 
(NA%)
1529
(18.7%)
1867
(23.6%)
2645
(1111%)
3513
(26.0%)
3948
(28.6%)
4552
(23.7%)
5284
(21.0%)
6089
(32.3%)
6964
(12.2%)
7803
(8.5%)
NA [2] 
(NA%)
[1]
Geometric CV was not calculated as data were available for only two participants.
[2]
Geometric mean and CV were not calculated as data were available for only one participant.
8.Secondary Outcome
Title Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor
Hide Description Apparent volume of distribution was calculated as Dose/ (kel *AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram [kg]).
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 2 6 12 12 21 13 8 9 7 3 4 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per kilogram (L/kg)
1.6 [1] 
(NA%)
1.5 [1] 
(NA%)
1.9
(21.2%)
1.9
(29.9%)
1.9
(34.1%)
1.7
(24.1%)
2.0
(30.3%)
1.7
(29.1%)
1.8
(12.9%)
1.9
(27.9%)
1.6
(23.0%)
1.7
(13.4%)
NA [2] 
(NA%)
[1]
Geometric CV was not calculated as data were available for only two participants.
[2]
Geometric mean and CV were not calculated as data were available for only one participant.
9.Secondary Outcome
Title Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor
Hide Description Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 2 6 12 12 21 13 8 9 7 3 4 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter per hour per kilogram (L/h/kg)
0.19 [1] 
(NA%)
0.21 [1] 
(NA%)
0.21
(26.6%)
0.22
(22.8%)
0.20
(54.9%)
0.21
(25.3%)
0.22
(25.9%)
0.23
(26.2%)
0.22
(12.9%)
0.20
(24.6%)
0.19
(27.5%)
0.22
(7.8%)
NA [2] 
(NA%)
[1]
Geometric CV was not calculated as data were available for only two participants.
[2]
Geometric mean and CV were not calculated as data were available for only one participant.
10.Secondary Outcome
Title Terminal Half-Life (t½) of Selinexor
Hide Description t½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.
Time Frame 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Selinexor (3 mg/m^2) Selinexor (6 mg/m^2) Selinexor (12 mg/m^2) Selinexor (16.8 mg/m^2) Selinexor (23 mg/m^2) Selinexor (30 mg/m^2) Selinexor (35 mg/m^2) Selinexor (40 mg/m^2) Selinexor (46 mg/m^2) Selinexor (55 mg/m^2) Selinexor (60 mg/m^2) Selinexor (70 mg/m^2) Selinexor (80 mg/m^2)
Hide Arm/Group Description:
Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Participants received selinexor dose of 16.8 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Participants received selinexor dose of 23 mg/m^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Participants received selinexor dose of 30 mg/m^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Participants received selinexor dose of 35 mg/m^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Participants received selinexor dose of 40 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Participants received selinexor dose of 46 mg/m^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Participants received selinexor dose of 55 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Participants received selinexor dose of 60 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 70 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Participants received selinexor dose of 80 mg/m^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Overall Number of Participants Analyzed 2 2 6 12 12 21 13 8 9 7 3 4 1
Median (Full Range)
Unit of Measure: hour
NA [1] 
(5.5 to 6.1)
NA [1] 
(4.4 to 5.1)
6.2
(4.2 to 7.8)
6.1
(3.1 to 8.7)
6.9
(3.5 to 12.0)
5.8
(3.9 to 8.4)
6.2
(4.6 to 10.4)
4.8
(2.7 to 9.8)
5.7
(4.1 to 6.8)
6.6
(5.4 to 10.1)
5.9
(4.3 to 5.9)
5.2
(5.0 to 6.0)
NA [1] 
(5.5 to 5.5)
[1]
Median value was not calculated due to insufficient PK samples required for calculation.
11.Secondary Outcome
Title Number of Participants With Overall Response of Selinexor
Hide Description Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).
Time Frame From first dose of study drug administration to end of treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 58 27 81 95 24
Measure Type: Number
Unit of Measure: participants
Complete response 5 1 0 0 0
Partial response 7 8 6 0 0
Morphologic complete remission 0 0 0 4 0
Partial remission 0 0 0 3 1
Complete cytogenetic response 0 0 0 0 0
Complete hematological response 0 0 0 0 0
12.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.
Time Frame From first dose of study drug administration to end of treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 12 9 7 11 1
Median (95% Confidence Interval)
Unit of Measure: Days
335.5 [1] 
(48 to NA)
251 [2] 
(36 to NA)
180 [2] 
(57 to NA)
76 [2] 
(29 to NA)
NA [3] 
(NA to NA)
[1]
Upper limit of 95% Confidence Interval (CI) was not estimable due to less than 50% death events.
[2]
Upper limit of 95% CI was not estimable due to less than 50% death events.
[3]
Median and limits of 95% CI were not estimable due to less than 50% death events.
13.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.
Time Frame Cycle 1 Day 1 to End of Treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 58 27 81 95 24
Median (95% Confidence Interval)
Unit of Measure: Days
47
(31 to 56)
110
(28 to 274)
57
(36 to 88)
44
(36 to 52)
57
(24 to 222)
14.Secondary Outcome
Title Duration of at Least Stable Disease
Hide Description Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.
Time Frame Cycle 1 Day 1 to End of Treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 58 27 81 95 24
Median (95% Confidence Interval)
Unit of Measure: Days
52
(32 to 79)
114
(43 to 415)
57
(43 to 100)
80
(52 to 101)
64
(21 to 283)
15.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.
Time Frame Cycle 1 Day 1 to End of Treatment (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description:
Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
Overall Number of Participants Analyzed 58 27 81 95 24
Median (95% Confidence Interval)
Unit of Measure: Days
138 [1] 
(85 to NA)
423 [1] 
(423 to NA)
366 [1] 
(126 to NA)
76
(48 to 114)
82 [1] 
(50 to NA)
[1]
Upper limit of 95% CI was not estimable due to less than 50% death events.
Time Frame From first dose of study drug administration to end of treatment (up to 27 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Hide Arm/Group Description Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses. Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses. Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses. Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
All-Cause Mortality
Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/58 (56.90%)   7/27 (25.93%)   52/81 (64.20%)   73/95 (76.84%)   13/24 (54.17%) 
Blood and lymphatic system disorders           
Febrile neutropenia * 1  4/58 (6.90%)  1/27 (3.70%)  6/81 (7.41%)  12/95 (12.63%)  0/24 (0.00%) 
Thrombocytopenia * 1  0/58 (0.00%)  0/27 (0.00%)  4/81 (4.94%)  2/95 (2.11%)  0/24 (0.00%) 
Anaemia * 1  2/58 (3.45%)  0/27 (0.00%)  2/81 (2.47%)  1/95 (1.05%)  0/24 (0.00%) 
Hyperviscosity syndrome * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Leukocytosis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Leukostasis syndrome * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Pancytopenia * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Cardiac disorders           
Tachycardia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Atrial fibrillation * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Cardiac arrest * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Cardiac failure * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Left ventricular dysfunction * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Palpitations * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Eye disorders           
Cataract * 1  0/58 (0.00%)  1/27 (3.70%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Eye haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Retinal detachment * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Vision blurred * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Vitreous detachment * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders           
Vomiting * 1  2/58 (3.45%)  0/27 (0.00%)  1/81 (1.23%)  3/95 (3.16%)  1/24 (4.17%) 
Abdominal pain * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  1/95 (1.05%)  0/24 (0.00%) 
Ascites * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Diarrhoea * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Gastric haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Nausea * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  1/95 (1.05%)  0/24 (0.00%) 
Constipation * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Dysphagia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Gastrointestinal haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Haematochezia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Haemorrhoidal haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Lower gastrointestinal haemorrhage * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Mouth haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Obstruction gastric * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Pancreatitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Small intestinal obstruction * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Stomatitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Upper gastrointestinal haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
General disorders           
Pyrexia * 1  3/58 (5.17%)  0/27 (0.00%)  5/81 (6.17%)  1/95 (1.05%)  0/24 (0.00%) 
Fatigue * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  6/95 (6.32%)  0/24 (0.00%) 
Death * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  3/95 (3.16%)  1/24 (4.17%) 
Asthenia * 1  1/58 (1.72%)  0/27 (0.00%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Disease progression * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Multiple organ dysfunction syndrome * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Gait disturbance * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  1/24 (4.17%) 
Non-cardiac chest pain * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Pain * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Performance status decreased * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Sudden death * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Unevaluable event * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Confusional state * 1  3/58 (5.17%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Hepatobiliary disorders           
Bile duct obstruction * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Cholecystitis acute * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Hyperbilirubinaemia * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Infections and infestations           
Pneumonia * 1  2/58 (3.45%)  0/27 (0.00%)  8/81 (9.88%)  10/95 (10.53%)  2/24 (8.33%) 
Sepsis * 1  3/58 (5.17%)  1/27 (3.70%)  2/81 (2.47%)  14/95 (14.74%)  0/24 (0.00%) 
Lung infection * 1  2/58 (3.45%)  1/27 (3.70%)  1/81 (1.23%)  4/95 (4.21%)  2/24 (8.33%) 
Bacteraemia * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  4/95 (4.21%)  1/24 (4.17%) 
Staphylococcal infection * 1  0/58 (0.00%)  1/27 (3.70%)  0/81 (0.00%)  3/95 (3.16%)  0/24 (0.00%) 
Upper respiratory tract infection * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  2/95 (2.11%)  0/24 (0.00%) 
Appendicitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Cellulitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Device related infection * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Epiglottitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Escherichia bacteraemia * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Escherichia sepsis * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Gastroenteritis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Infection * 1  0/58 (0.00%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Localised infection * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Lower respiratory tract infection * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Lung infection pseudomonal * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Mastoiditis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Mucormycosis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Pharyngitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Pneumonia fungal * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Pseudomonal bacteraemia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Respiratory syncytial virus infection * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Sinusitis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Skin infection * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Urinary tract infection * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Urosepsis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  1/24 (4.17%) 
Viral upper respiratory tract infection * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications           
Fall * 1  1/58 (1.72%)  0/27 (0.00%)  1/81 (1.23%)  2/95 (2.11%)  0/24 (0.00%) 
Contusion * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Overdose * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  1/24 (4.17%) 
Post procedural haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Rib fracture * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Spinal fracture * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Transfusion reaction * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Wrist fracture * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Blood alkaline phosphatase increased * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Investigations           
Aspartate aminotransferase increased * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  1/95 (1.05%)  0/24 (0.00%) 
Ejection fraction decreased * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  1/24 (4.17%) 
Alanine aminotransferase increased * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Metabolism and nutrition disorders           
Dehydration * 1  2/58 (3.45%)  0/27 (0.00%)  3/81 (3.70%)  5/95 (5.26%)  0/24 (0.00%) 
Hyponatraemia * 1  0/58 (0.00%)  1/27 (3.70%)  2/81 (2.47%)  0/95 (0.00%)  1/24 (4.17%) 
Fluid overload * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Hypercalcaemia * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  1/24 (4.17%) 
Hypoglycaemia * 1  1/58 (1.72%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Decreased appetite * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Hyperamylasaemia * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Hypercreatininaemia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Hyperglycaemia * 1  0/58 (0.00%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Hyperkalaemia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Hypophosphataemia * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Headache * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders           
Muscular weakness * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Flank pain * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Joint effusion * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant neoplasm progression * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  4/95 (4.21%)  0/24 (0.00%) 
Tumour pain * 1  0/58 (0.00%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Nervous system disorders           
Central nervous system haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Cerebral haemorrhage * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  1/95 (1.05%)  0/24 (0.00%) 
Encephalopathy * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  1/95 (1.05%)  0/24 (0.00%) 
Seizure * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Dysarthria * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Encephalitis toxic * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Facial paralysis * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Guillain-Barre syndrome * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Haemorrhage intracranial * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Lethargy * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Nervous system disorder * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Somnolence * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Spinal cord compression * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Syncope * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Transient ischaemic attack * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  1/24 (4.17%) 
Psychiatric disorders           
Delirium * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Suicide attempt * 1  1/58 (1.72%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Psychotic disorder * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Renal and urinary disorders           
Acute kidney injury * 1  1/58 (1.72%)  0/27 (0.00%)  4/81 (4.94%)  1/95 (1.05%)  0/24 (0.00%) 
Renal impairment * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Urinary tract obstruction * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Hypoxia * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  2/95 (2.11%)  0/24 (0.00%) 
Dyspnoea * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  1/24 (4.17%) 
Epistaxis * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  2/95 (2.11%)  0/24 (0.00%) 
Respiratory failure * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  3/95 (3.16%)  0/24 (0.00%) 
Haemoptysis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Pleural effusion * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Pneumonia aspiration * 1  1/58 (1.72%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Pulmonary embolism * 1  1/58 (1.72%)  1/27 (3.70%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Pulmonary oedema * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Acute respiratory distress syndrome * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Lung consolidation * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  1/24 (4.17%) 
Pneumothorax * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Respiratory arrest * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  1/95 (1.05%)  1/24 (4.17%) 
Skin and subcutaneous tissue disorders           
Swelling face * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Surgical and medical procedures           
Small intestinal resection * 1  1/58 (1.72%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Vascular disorders           
Embolism * 1  2/58 (3.45%)  0/27 (0.00%)  0/81 (0.00%)  2/95 (2.11%)  0/24 (0.00%) 
Hypotension * 1  1/58 (1.72%)  0/27 (0.00%)  2/81 (2.47%)  1/95 (1.05%)  0/24 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diffuse Large B-cell Lymphoma (DLBCL) Non-Hodgkin Lymphoma (NHL) Excluding DLBCL Multiple Myeloma (MM) Acute Myeloid Leukemia (AML) Other Hematological Malignancies (ALL, CML and CLL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   58/58 (100.00%)   27/27 (100.00%)   80/81 (98.77%)   94/95 (98.95%)   24/24 (100.00%) 
Blood and lymphatic system disorders           
Thrombocytopenia * 1  39/58 (67.24%)  15/27 (55.56%)  52/81 (64.20%)  47/95 (49.47%)  17/24 (70.83%) 
Anaemia * 1  34/58 (58.62%)  14/27 (51.85%)  42/81 (51.85%)  46/95 (48.42%)  16/24 (66.67%) 
Neutropenia * 1  23/58 (39.66%)  12/27 (44.44%)  31/81 (38.27%)  23/95 (24.21%)  10/24 (41.67%) 
Leukopenia * 1  11/58 (18.97%)  5/27 (18.52%)  11/81 (13.58%)  15/95 (15.79%)  8/24 (33.33%) 
Lymphopenia * 1  6/58 (10.34%)  2/27 (7.41%)  7/81 (8.64%)  7/95 (7.37%)  6/24 (25.00%) 
Febrile neutropenia * 1  1/58 (1.72%)  1/27 (3.70%)  3/81 (3.70%)  13/95 (13.68%)  1/24 (4.17%) 
Leukocytosis * 1  0/58 (0.00%)  0/27 (0.00%)  0/81 (0.00%)  9/95 (9.47%)  3/24 (12.50%) 
Cardiac disorders           
Tachycardia * 1  1/58 (1.72%)  1/27 (3.70%)  4/81 (4.94%)  3/95 (3.16%)  2/24 (8.33%) 
Sinus tachycardia * 1  4/58 (6.90%)  0/27 (0.00%)  1/81 (1.23%)  3/95 (3.16%)  0/24 (0.00%) 
Palpitations * 1  2/58 (3.45%)  2/27 (7.41%)  1/81 (1.23%)  0/95 (0.00%)  1/24 (4.17%) 
Ear and labyrinth disorders           
Hypoacusis * 1  3/58 (5.17%)  1/27 (3.70%)  2/81 (2.47%)  3/95 (3.16%)  0/24 (0.00%) 
Tinnitus * 1  0/58 (0.00%)  1/27 (3.70%)  1/81 (1.23%)  5/95 (5.26%)  0/24 (0.00%) 
Eye disorders           
Vision blurred * 1  15/58 (25.86%)  4/27 (14.81%)  21/81 (25.93%)  21/95 (22.11%)  6/24 (25.00%) 
Cataract * 1  2/58 (3.45%)  2/27 (7.41%)  6/81 (7.41%)  3/95 (3.16%)  1/24 (4.17%) 
Visual impairment * 1  5/58 (8.62%)  1/27 (3.70%)  3/81 (3.70%)  1/95 (1.05%)  0/24 (0.00%) 
Photopsia * 1  2/58 (3.45%)  0/27 (0.00%)  5/81 (6.17%)  0/95 (0.00%)  2/24 (8.33%) 
Dry eye * 1  2/58 (3.45%)  2/27 (7.41%)  1/81 (1.23%)  2/95 (2.11%)  0/24 (0.00%) 
Eye pain * 1  0/58 (0.00%)  3/27 (11.11%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders           
Nausea * 1  38/58 (65.52%)  18/27 (66.67%)  64/81 (79.01%)  55/95 (57.89%)  18/24 (75.00%) 
Vomiting * 1  25/58 (43.10%)  11/27 (40.74%)  40/81 (49.38%)  39/95 (41.05%)  9/24 (37.50%) 
Diarrhoea * 1  24/58 (41.38%)  9/27 (33.33%)  32/81 (39.51%)  46/95 (48.42%)  10/24 (41.67%) 
Constipation * 1  15/58 (25.86%)  9/27 (33.33%)  15/81 (18.52%)  29/95 (30.53%)  6/24 (25.00%) 
Abdominal pain * 1  11/58 (18.97%)  3/27 (11.11%)  9/81 (11.11%)  10/95 (10.53%)  4/24 (16.67%) 
Dyspepsia * 1  8/58 (13.79%)  2/27 (7.41%)  9/81 (11.11%)  5/95 (5.26%)  1/24 (4.17%) 
Stomatitis * 1  4/58 (6.90%)  1/27 (3.70%)  1/81 (1.23%)  17/95 (17.89%)  2/24 (8.33%) 
Dysphagia * 1  3/58 (5.17%)  1/27 (3.70%)  5/81 (6.17%)  5/95 (5.26%)  0/24 (0.00%) 
Dry mouth * 1  2/58 (3.45%)  2/27 (7.41%)  3/81 (3.70%)  6/95 (6.32%)  0/24 (0.00%) 
Gingival bleeding * 1  1/58 (1.72%)  1/27 (3.70%)  3/81 (3.70%)  5/95 (5.26%)  0/24 (0.00%) 
Haemorrhoids * 1  0/58 (0.00%)  0/27 (0.00%)  2/81 (2.47%)  6/95 (6.32%)  0/24 (0.00%) 
General disorders           
Fatigue * 1  39/58 (67.24%)  13/27 (48.15%)  62/81 (76.54%)  67/95 (70.53%)  16/24 (66.67%) 
Pyrexia * 1  21/58 (36.21%)  4/27 (14.81%)  22/81 (27.16%)  20/95 (21.05%)  1/24 (4.17%) 
Oedema peripheral * 1  13/58 (22.41%)  2/27 (7.41%)  8/81 (9.88%)  21/95 (22.11%)  2/24 (8.33%) 
Asthenia * 1  2/58 (3.45%)  4/27 (14.81%)  14/81 (17.28%)  7/95 (7.37%)  0/24 (0.00%) 
Chills * 1  4/58 (6.90%)  5/27 (18.52%)  7/81 (8.64%)  7/95 (7.37%)  2/24 (8.33%) 
Gait disturbance * 1  6/58 (10.34%)  1/27 (3.70%)  7/81 (8.64%)  2/95 (2.11%)  2/24 (8.33%) 
Malaise * 1  5/58 (8.62%)  2/27 (7.41%)  5/81 (6.17%)  2/95 (2.11%)  1/24 (4.17%) 
Non-cardiac chest pain * 1  2/58 (3.45%)  1/27 (3.70%)  8/81 (9.88%)  4/95 (4.21%)  0/24 (0.00%) 
Oedema * 1  2/58 (3.45%)  0/27 (0.00%)  1/81 (1.23%)  5/95 (5.26%)  1/24 (4.17%) 
Peripheral swelling * 1  4/58 (6.90%)  0/27 (0.00%)  1/81 (1.23%)  0/95 (0.00%)  0/24 (0.00%) 
Hepatobiliary disorders           
Hyperbilirubinaemia * 1  0/58 (0.00%)  0/27 (0.00%)  4/81 (4.94%)  4/95 (4.21%)  2/24 (8.33%) 
Infections and infestations           
Urinary tract infection * 1  5/58 (8.62%)  3/27 (11.11%)  7/81 (8.64%)  5/95 (5.26%)  4/24 (16.67%) 
Upper respiratory tract infection * 1  2/58 (3.45%)  2/27 (7.41%)  9/81 (11.11%)  4/95 (4.21%)  1/24 (4.17%) 
Lung infection * 1  5/58 (8.62%)  2/27 (7.41%)  3/81 (3.70%)  3/95 (3.16%)  1/24 (4.17%) 
Pneumonia * 1  0/58 (0.00%)  0/27 (0.00%)  4/81 (4.94%)  9/95 (9.47%)  1/24 (4.17%) 
Oral infection * 1  0/58 (0.00%)  2/27 (7.41%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications           
Fall * 1  4/58 (6.90%)  2/27 (7.41%)  8/81 (9.88%)  8/95 (8.42%)  4/24 (16.67%) 
Contusion * 1  3/58 (5.17%)  0/27 (0.00%)  6/81 (7.41%)  5/95 (5.26%)  4/24 (16.67%) 
Investigations           
Weight decreased * 1  14/58 (24.14%)  10/27 (37.04%)  32/81 (39.51%)  31/95 (32.63%)  3/24 (12.50%) 
Alanine aminotransferase increased * 1  7/58 (12.07%)  2/27 (7.41%)  8/81 (9.88%)  10/95 (10.53%)  2/24 (8.33%) 
Aspartate aminotransferase increased * 1  5/58 (8.62%)  1/27 (3.70%)  7/81 (8.64%)  10/95 (10.53%)  2/24 (8.33%) 
Electrocardiogram QT prolonged * 1  2/58 (3.45%)  1/27 (3.70%)  3/81 (3.70%)  10/95 (10.53%)  5/24 (20.83%) 
International normalised ratio increased * 1  0/58 (0.00%)  0/27 (0.00%)  3/81 (3.70%)  7/95 (7.37%)  0/24 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  34/58 (58.62%)  16/27 (59.26%)  54/81 (66.67%)  62/95 (65.26%)  13/24 (54.17%) 
Hyponatraemia * 1  25/58 (43.10%)  7/27 (25.93%)  36/81 (44.44%)  34/95 (35.79%)  11/24 (45.83%) 
Hypokalaemia * 1  14/58 (24.14%)  5/27 (18.52%)  12/81 (14.81%)  22/95 (23.16%)  2/24 (8.33%) 
Dehydration * 1  7/58 (12.07%)  4/27 (14.81%)  27/81 (33.33%)  15/95 (15.79%)  1/24 (4.17%) 
Hypercreatininaemia * 1  10/58 (17.24%)  0/27 (0.00%)  23/81 (28.40%)  18/95 (18.95%)  3/24 (12.50%) 
Hypomagnesaemia * 1  14/58 (24.14%)  4/27 (14.81%)  6/81 (7.41%)  19/95 (20.00%)  1/24 (4.17%) 
Hyperglycaemia * 1  8/58 (13.79%)  7/27 (25.93%)  6/81 (7.41%)  18/95 (18.95%)  3/24 (12.50%) 
Hypocalcaemia * 1  4/58 (6.90%)  6/27 (22.22%)  7/81 (8.64%)  18/95 (18.95%)  3/24 (12.50%) 
Hypophosphataemia * 1  6/58 (10.34%)  4/27 (14.81%)  6/81 (7.41%)  13/95 (13.68%)  1/24 (4.17%) 
Hyperkalaemia * 1  4/58 (6.90%)  3/27 (11.11%)  3/81 (3.70%)  11/95 (11.58%)  1/24 (4.17%) 
Hyperuricaemia * 1  2/58 (3.45%)  4/27 (14.81%)  5/81 (6.17%)  9/95 (9.47%)  1/24 (4.17%) 
Hypoalbuminaemia * 1  5/58 (8.62%)  1/27 (3.70%)  1/81 (1.23%)  10/95 (10.53%)  1/24 (4.17%) 
Hyperamylasaemia * 1  5/58 (8.62%)  0/27 (0.00%)  3/81 (3.70%)  6/95 (6.32%)  0/24 (0.00%) 
Hyperlipasaemia * 1  2/58 (3.45%)  0/27 (0.00%)  6/81 (7.41%)  5/95 (5.26%)  0/24 (0.00%) 
Hypermagnesaemia * 1  3/58 (5.17%)  2/27 (7.41%)  1/81 (1.23%)  2/95 (2.11%)  0/24 (0.00%) 
Hypercalcaemia * 1  0/58 (0.00%)  1/27 (3.70%)  3/81 (3.70%)  1/95 (1.05%)  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  12/58 (20.69%)  2/27 (7.41%)  19/81 (23.46%)  13/95 (13.68%)  1/24 (4.17%) 
Muscular weakness * 1  9/58 (15.52%)  4/27 (14.81%)  13/81 (16.05%)  15/95 (15.79%)  3/24 (12.50%) 
Arthralgia * 1  3/58 (5.17%)  1/27 (3.70%)  7/81 (8.64%)  14/95 (14.74%)  4/24 (16.67%) 
Pain in extremity * 1  4/58 (6.90%)  2/27 (7.41%)  6/81 (7.41%)  6/95 (6.32%)  1/24 (4.17%) 
Myalgia * 1  4/58 (6.90%)  2/27 (7.41%)  5/81 (6.17%)  6/95 (6.32%)  1/24 (4.17%) 
Muscle spasms * 1  4/58 (6.90%)  1/27 (3.70%)  6/81 (7.41%)  4/95 (4.21%)  0/24 (0.00%) 
Musculoskeletal chest pain * 1  4/58 (6.90%)  2/27 (7.41%)  5/81 (6.17%)  0/95 (0.00%)  1/24 (4.17%) 
Neck pain * 1  3/58 (5.17%)  2/27 (7.41%)  2/81 (2.47%)  2/95 (2.11%)  0/24 (0.00%) 
Bone pain * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  5/95 (5.26%)  0/24 (0.00%) 
Nervous system disorders           
Dysgeusia * 1  13/58 (22.41%)  6/27 (22.22%)  16/81 (19.75%)  22/95 (23.16%)  1/24 (4.17%) 
Dizziness * 1  14/58 (24.14%)  5/27 (18.52%)  13/81 (16.05%)  20/95 (21.05%)  5/24 (20.83%) 
Headache * 1  7/58 (12.07%)  4/27 (14.81%)  11/81 (13.58%)  16/95 (16.84%)  5/24 (20.83%) 
Peripheral sensory neuropathy * 1  2/58 (3.45%)  2/27 (7.41%)  4/81 (4.94%)  2/95 (2.11%)  4/24 (16.67%) 
Neuropathy peripheral * 1  6/58 (10.34%)  2/27 (7.41%)  2/81 (2.47%)  3/95 (3.16%)  0/24 (0.00%) 
Syncope * 1  2/58 (3.45%)  2/27 (7.41%)  5/81 (6.17%)  3/95 (3.16%)  0/24 (0.00%) 
Amnesia * 1  1/58 (1.72%)  2/27 (7.41%)  1/81 (1.23%)  3/95 (3.16%)  0/24 (0.00%) 
Balance disorder * 1  3/58 (5.17%)  2/27 (7.41%)  2/81 (2.47%)  0/95 (0.00%)  0/24 (0.00%) 
Dysarthria * 1  3/58 (5.17%)  1/27 (3.70%)  0/81 (0.00%)  1/95 (1.05%)  0/24 (0.00%) 
Psychiatric disorders           
Confusional state * 1  8/58 (13.79%)  8/27 (29.63%)  15/81 (18.52%)  15/95 (15.79%)  2/24 (8.33%) 
Insomnia * 1  8/58 (13.79%)  4/27 (14.81%)  8/81 (9.88%)  9/95 (9.47%)  2/24 (8.33%) 
Anxiety * 1  7/58 (12.07%)  0/27 (0.00%)  4/81 (4.94%)  7/95 (7.37%)  0/24 (0.00%) 
Depression * 1  3/58 (5.17%)  2/27 (7.41%)  6/81 (7.41%)  4/95 (4.21%)  1/24 (4.17%) 
Agitation * 1  5/58 (8.62%)  0/27 (0.00%)  6/81 (7.41%)  2/95 (2.11%)  2/24 (8.33%) 
Renal and urinary disorders           
Haematuria * 1  3/58 (5.17%)  1/27 (3.70%)  5/81 (6.17%)  6/95 (6.32%)  3/24 (12.50%) 
Proteinuria * 1  3/58 (5.17%)  2/27 (7.41%)  4/81 (4.94%)  3/95 (3.16%)  4/24 (16.67%) 
Urinary incontinence * 1  1/58 (1.72%)  3/27 (11.11%)  2/81 (2.47%)  2/95 (2.11%)  2/24 (8.33%) 
Pollakiuria * 1  2/58 (3.45%)  0/27 (0.00%)  2/81 (2.47%)  5/95 (5.26%)  0/24 (0.00%) 
Dysuria * 1  0/58 (0.00%)  0/27 (0.00%)  1/81 (1.23%)  4/95 (4.21%)  2/24 (8.33%) 
Urinary retention * 1  3/58 (5.17%)  0/27 (0.00%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  15/58 (25.86%)  8/27 (29.63%)  20/81 (24.69%)  32/95 (33.68%)  6/24 (25.00%) 
Cough * 1  15/58 (25.86%)  6/27 (22.22%)  18/81 (22.22%)  15/95 (15.79%)  3/24 (12.50%) 
Epistaxis * 1  6/58 (10.34%)  1/27 (3.70%)  16/81 (19.75%)  23/95 (24.21%)  3/24 (12.50%) 
Productive cough * 1  6/58 (10.34%)  5/27 (18.52%)  1/81 (1.23%)  6/95 (6.32%)  0/24 (0.00%) 
Oropharyngeal pain * 1  1/58 (1.72%)  3/27 (11.11%)  2/81 (2.47%)  6/95 (6.32%)  0/24 (0.00%) 
Nasal congestion * 1  4/58 (6.90%)  0/27 (0.00%)  3/81 (3.70%)  2/95 (2.11%)  1/24 (4.17%) 
Pleural effusion * 1  3/58 (5.17%)  1/27 (3.70%)  3/81 (3.70%)  1/95 (1.05%)  1/24 (4.17%) 
Rhinorrhoea * 1  1/58 (1.72%)  1/27 (3.70%)  1/81 (1.23%)  5/95 (5.26%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders           
Night sweats * 1  6/58 (10.34%)  2/27 (7.41%)  6/81 (7.41%)  5/95 (5.26%)  3/24 (12.50%) 
Alopecia * 1  2/58 (3.45%)  3/27 (11.11%)  7/81 (8.64%)  2/95 (2.11%)  2/24 (8.33%) 
Petechiae * 1  0/58 (0.00%)  1/27 (3.70%)  5/81 (6.17%)  8/95 (8.42%)  2/24 (8.33%) 
Hyperhidrosis * 1  2/58 (3.45%)  2/27 (7.41%)  5/81 (6.17%)  6/95 (6.32%)  0/24 (0.00%) 
Skin lesion * 1  0/58 (0.00%)  2/27 (7.41%)  1/81 (1.23%)  3/95 (3.16%)  0/24 (0.00%) 
Vascular disorders           
Hypotension * 1  7/58 (12.07%)  5/27 (18.52%)  9/81 (11.11%)  19/95 (20.00%)  2/24 (8.33%) 
Hypertension * 1  5/58 (8.62%)  2/27 (7.41%)  1/81 (1.23%)  9/95 (9.47%)  3/24 (12.50%) 
Orthostatic hypotension * 1  1/58 (1.72%)  1/27 (3.70%)  0/81 (0.00%)  5/95 (5.26%)  0/24 (0.00%) 
Hot flush * 1  1/58 (1.72%)  2/27 (7.41%)  0/81 (0.00%)  0/95 (0.00%)  0/24 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jatin Shah, MD
Organization: Karyopharm Therapeutics Inc.
Phone: (617) 658-0600
EMail: jshah@karyopharm.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT01607892    
Other Study ID Numbers: KCP-330-001
First Submitted: May 16, 2012
First Posted: May 30, 2012
Results First Submitted: February 1, 2021
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021