Trial Outcomes & Findings for A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma (NCT NCT01896505)
NCT ID: NCT01896505
Last Updated: 2024-01-08
Results Overview
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dose
Results posted on
2024-01-08
Participant Flow
This study was conducted at 2 sites in United States and Canada from 30 July 2013 to 21 October 2016.
A total of 54 participants were enrolled and randomized to study treatment.
Participant milestones
| Measure |
Arm 1:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 2:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arm 4:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 5:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 6:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
17
|
7
|
5
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
17
|
7
|
5
|
6
|
Reasons for withdrawal
| Measure |
Arm 1:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 2:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arm 4:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 5:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 6:
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
3
|
2
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
1
|
0
|
0
|
|
Overall Study
Disease Progression
|
7
|
5
|
8
|
4
|
4
|
4
|
|
Overall Study
Need of treatment not allowed per protocol
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Intercurrent illness
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Baseline characteristics by cohort
| Measure |
Arm 1:
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arm 4:
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 5:
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 6:
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.7 Years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
57.6 Years
STANDARD_DEVIATION 17.18 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
53.4 Years
STANDARD_DEVIATION 8.10 • n=4 Participants
|
43.6 Years
STANDARD_DEVIATION 19.32 • n=21 Participants
|
53.8 Years
STANDARD_DEVIATION 11.62 • n=10 Participants
|
55.0 Years
STANDARD_DEVIATION 14.22 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dosePopulation: Pharmacokinetic (PK) population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor
|
3175 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25.3
|
3280 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 19.3
|
2752 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 37.5
|
3342 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21.4
|
4086 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22.3
|
4220 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22.0
|
3955 Nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 21.2
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), AUC0-inf was calculated as AUC0-t + Ct/ elimination rate constant (kel), where: Ct = the last observed non- zero concentration.
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor
|
3412 ng*h/mL
Geometric Coefficient of Variation 23.8
|
3483 ng*h/mL
Geometric Coefficient of Variation 18.1
|
2969 ng*h/mL
Geometric Coefficient of Variation 34.1
|
3561 ng*h/mL
Geometric Coefficient of Variation 20.6
|
4117 ng*h/mL
Geometric Coefficient of Variation 22.4
|
4250 ng*h/mL
Geometric Coefficient of Variation 21.8
|
4002 ng*h/mL
Geometric Coefficient of Variation 21.1
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Selinexor
|
404 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39.1
|
436 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.9
|
355 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.6
|
429 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.1
|
519 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34.4
|
527 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.7
|
450 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 52.8
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Time of First Maximum Observed Concentration (Tmax) of Selinexor
|
3.4 Hour
Interval 1.5 to 8.0
|
3.4 Hour
Interval 1.4 to 6.1
|
1.5 Hour
Interval 1.0 to 6.1
|
3.8 Hour
Interval 1.5 to 5.0
|
2.1 Hour
Interval 0.6 to 5.1
|
3.0 Hour
Interval 1.0 to 4.2
|
1.6 Hour
Interval 1.0 to 9.7
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
t1/2 was the terminal phase half-life, it was calculated as ln(2)/kel.
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Half-Life (t1/2) of Selinexor
|
5.9 Hour
Standard Deviation 1.36
|
5.6 Hour
Standard Deviation 1.00
|
6.2 Hour
Standard Deviation 1.71
|
5.7 Hour
Standard Deviation 1.06
|
6.7 Hour
Standard Deviation 1.34
|
6.6 Hour
Standard Deviation 1.14
|
6.5 Hour
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \[kg\]).
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Selinexor
|
0.22 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 21.3
|
0.22 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 16.3
|
0.3 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 32.1
|
0.21 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 18.7
|
0.21 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 20.6
|
0.20 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 16.6
|
0.21 Liter per hour per kilogram (L/h/kg)
Geometric Coefficient of Variation 14.2
|
PRIMARY outcome
Timeframe: Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dosePopulation: PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.
Vd/F was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).
Outcome measures
| Measure |
Arm 2:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=14 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
n=13 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) of Selinexor
|
1.8 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 32.3
|
1.7 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 26.1
|
2.2 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 49.5
|
1.7 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 26.6
|
2.0 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 16.9
|
1.9 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 18.3
|
1.9 Liter per kilogram (L/kg)
Geometric Coefficient of Variation 18.2
|
SECONDARY outcome
Timeframe: From the date of first documented response until the date of documented progression or last disease assessment (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure analysis was planned to be analyzed as per disease specific sarcoma.
Best overall response rate was defined as the percentage of participants who achieved complete response (CR), and partial response (PR), as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to less than (\<) 10 millimeter (mm). PR was defined as At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter (LD).
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=23 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=19 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria
Complete Response (CR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria
Partial Response (PR)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression, censored date (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.
Duration of at least stable disease was defined as the time from the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression as per RECIST v1.1 Criteria. Participants without evidence of progression were censored at time of last disease assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=23 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=19 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Duration of Stable Disease as Per RECIST v1.1 Criteria
|
3.94 Months
Interval 1.64 to 5.55
|
8.34 Months
Interval 3.09 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
7.49 Months
Interval 3.55 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to time of disease progression or death, censored date (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.
PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST v1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. Participants who were last known to be alive and without evidence of progression were censored at time of last disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, or 30 days after end of treatment, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=23 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=19 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) as Per RECIST v1.1 Criteria
|
3.52 Months
Interval 1.48 to 5.55
|
1.84 Months
Interval 1.02 to 3.58
|
4.44 Months
Interval 2.07 to 7.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to death, censored date (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.
OS was defined as the time from date first dose of study treatment to the date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropped out prior to study end, were censored at the day they were last known to be alive.
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=23 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=19 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
7.03 Months
Interval 5.75 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
NA Months
Interval 3.38 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
9.00 Months
Interval 4.76 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to first documented evidence of disease recurrence or progression, or death, censored date (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma.
TTP was defined as the time from date of first dose of study treatment to first documented evidence of disease recurrence or progression, or death due to disease progression, whichever occurred first. Participants without evidence of progression were censored at time of last evaluable disease assessment.
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=23 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=19 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
3.52 Months
Interval 1.48 to 5.55
|
1.74 Months
Interval 1.02 to 5.55
|
4.44 Months
Interval 2.07 to
Data could not be estimated due to higher number (\>50%) of censored participants.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma. Here 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
GMI was defined as the ratio between the TTP with selinexor and the TTP with the most recent prior treatment. GMI was calculated, using a previously described threshold of 1.3 or greater as a sign of potential drug activity and improved overall survival.
Outcome measures
| Measure |
Arm 2:
n=12 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=20 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=18 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Growth Modulation Index (GMI) Less Than or Equal to (<=) 1.33 and Greater Than (>) 1.33
GMI <= 1.33
|
8 Participants
|
17 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Growth Modulation Index (GMI) Less Than or Equal to (<=) 1.33 and Greater Than (>) 1.33
GMI > 1.33
|
4 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days post last study drug dose (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
An AE was any untoward medical occurrence in a 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. SAE defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, is life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.
Outcome measures
| Measure |
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
|
9 Participants
|
17 Participants
|
10 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
|
5 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days post last study drug dose (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 28 days following last dose or any event considered drug-related by the investigator through the end of the study. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.
Outcome measures
| Measure |
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Grade 1: Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Grade 2: Moderate
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Grade 3: Severe
|
5 Participants
|
14 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Grade 4: Life Threatening
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
Grade 5: Fatal
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days post last study drug dose (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
Number of participants with clinically significant laboratory abnormalities including clinical chemistry, hematology, coagulation and urinalysis. Number of participants with clinically significant laboratory abnormalities which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology
|
2 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Clinical Chemistry
|
1 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Coagulation: Prothrombin intl. normalized ratio
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days post last study drug dose (up to 39 months)Population: Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
Vital signs included blood pressure (systolic blood pressure and diastolic blood pressure). Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose based on the condition met (Yes/No). Number of participants with clinically significant changes in vital signs with condition (Yes) were only reported.
Outcome measures
| Measure |
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: < 60 mmHg and > 10 mmHg decrease from baseline (Yes)
|
2 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 5 mmHg increase from baseline (Yes)
|
5 Participants
|
13 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: < 100 mmHg (Yes)
|
5 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 10 mmHg decrease from baseline (Yes)
|
7 Participants
|
14 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 20 mmHg decrease from baseline (Yes)
|
4 Participants
|
10 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: < 100 mmHg and > 10 mmHg decrease from baseline (Yes)
|
4 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: < 100 mmHg and > 20 mmHg decrease from baseline (Yes)
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: < 60 mmHg (Yes)
|
3 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 5 mmHg decrease from baseline (Yes)
|
7 Participants
|
15 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 10 mmHg decrease from baseline (Yes)
|
5 Participants
|
12 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: < 60 mmHg and > 5 mmHg decrease from baseline (Yes)
|
2 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure : > 140 mmHg (Yes)
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 160 mmHg (Yes)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 10 mmHg increase from baseline (Yes)
|
6 Participants
|
11 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 20 mmHg increase from baseline (Yes)
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 160 mmHg and > 10 mmHg increase from baseline (Yes)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Systolic Blood Pressure: > 160 mmHg and > 20 mmHg increase from baseline (Yes)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 90 mmHg (Yes)
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 100 mmHg (Yes)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 10 mmHg increase from baseline (Yes)
|
4 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 100 mmHg and > 5 mmHg increase from baseline (Yes)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes in Vital Signs
Diastolic Blood Pressure: > 100 mmHg and > 10 mmHg increase from baseline (Yes)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days post last study drug dosePopulation: Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose.
Outcome measures
| Measure |
Arm 2:
n=9 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 3:
n=17 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arms 1 and 2: Treatment A: Fasted, Tablet Formulation
n=10 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).
|
Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation
n=7 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).
|
Arms 4, 5, and 6: Treatment A: First Generation Tablet
n=5 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment B: Second Generation Tablet
n=6 Participants
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
Arms 4, 5, and 6: Treatment C: Oral Suspension
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Arm 1:
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Arm 2:
Serious events: 5 serious events
Other events: 9 other events
Deaths: 2 deaths
Arm 3:
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
Arm 4:
Serious events: 2 serious events
Other events: 7 other events
Deaths: 3 deaths
Arm 5:
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Arm 6:
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1:
n=10 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 2:
n=9 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 3:
n=17 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arm 4:
n=7 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 5:
n=5 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 6:
n=6 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Death
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Embolism
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
Other adverse events
| Measure |
Arm 1:
n=10 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).
|
Arm 2:
n=9 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 3:
n=17 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.
|
Arm 4:
n=7 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 5:
n=5 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
Arm 6:
n=6 participants at risk
Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
77.8%
7/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
70.6%
12/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
80.0%
4/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
83.3%
5/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
88.9%
8/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
52.9%
9/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
100.0%
5/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
50.0%
3/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
77.8%
7/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
35.3%
6/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
50.0%
3/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
29.4%
5/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Left atrial enlargement
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
47.1%
8/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Photopsia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
88.9%
8/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
100.0%
17/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
85.7%
6/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
80.0%
4/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
83.3%
5/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
70.6%
12/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
42.9%
3/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
83.3%
5/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
70.6%
12/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
57.1%
4/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
60.0%
3/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
50.0%
3/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
44.4%
4/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
29.4%
5/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
50.0%
3/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Fatigue
|
80.0%
8/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
100.0%
9/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
94.1%
16/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
57.1%
4/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
100.0%
5/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
100.0%
6/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Oedema peripheral
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Chills
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Face oedema
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Thirst
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Generalised oedema
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
General disorders
Tenderness
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
17.6%
3/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Eye infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Cement embolism
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
47.1%
8/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Electrocardiogram QT prolonged
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Weight increased
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Body temperature increased
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Heart rate increased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Blood pressure increased
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
17.6%
3/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Urine output decreased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
44.4%
4/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
58.8%
10/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
57.1%
4/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
40.0%
4/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
35.3%
6/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
42.9%
3/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
50.0%
3/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
29.4%
5/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
44.4%
4/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Dysgeusia
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
55.6%
5/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
47.1%
8/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
66.7%
4/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
64.7%
11/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
42.9%
3/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Psychiatric disorders
Restlessness
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Haematuria
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Chromaturia
|
20.0%
2/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
5/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
41.2%
7/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
47.1%
8/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
40.0%
2/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
17.6%
3/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.8%
2/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
2/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
22.2%
2/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Nail cuticle fissure
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
17.6%
3/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
60.0%
3/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
11.1%
1/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
23.5%
4/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
28.6%
2/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Deep vein thrombosis
|
30.0%
3/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
44.4%
4/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
0.00%
0/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
33.3%
3/9 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
5.9%
1/17 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
14.3%
1/7 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
20.0%
1/5 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
16.7%
1/6 • From screening up to 30 days post last study drug dose (up to 39 months)
Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER