Trial Outcomes & Findings for Selinexor in Advanced Liposarcoma (NCT NCT02606461)

NCT ID: NCT02606461

Last Updated: 2023-01-23

Results Overview

PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST version 1.1, 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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

342 participants

Primary outcome timeframe

From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months)

Results posted on

2023-01-23

Participant Flow

The study was conducted at 71 sites in the United States, Canada, Germany, Belgium, Israel, United Kingdom, France, Spain, Italy, and Sweden. A total of 342 participants were enrolled, out of which 57 participants were randomized to receive study treatment in Phase 2 and 285 participants randomized, of which 284 participants received study treatment in Phase 3.

This study consisted of 2 phases (2 and 3), where participants were randomized to selinexor or placebo in double-blind treatment. Participants in the placebo group who had progressive disease (PD) during the phase 2 and 3 double-blinded treatment could crossover to open-label selinexor treatment.

Participant milestones

Participant milestones
Measure
Phase 2 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open-label: Selinexor
Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Phase 3 Open-label: Selinexor
Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Period 1: Double-blinded Period
STARTED
27
30
188
97
0
0
Period 1: Double-blinded Period
Treated
27
30
187
97
0
0
Period 1: Double-blinded Period
COMPLETED
27
30
187
97
0
0
Period 1: Double-blinded Period
NOT COMPLETED
0
0
1
0
0
0
Period 2: Open Label Period
STARTED
0
0
0
0
24
63
Period 2: Open Label Period
COMPLETED
0
0
0
0
24
63
Period 2: Open Label Period
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase 2 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 milligrams (mg) selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Selinexor
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open-label: Selinexor
Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Phase 3 Open-label: Selinexor
Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Period 1: Double-blinded Period
Randomized but no treatment
0
0
1
0
0
0

Baseline Characteristics

Selinexor in Advanced Liposarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase 2 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to Selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Total
n=342 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=93 Participants
17 Participants
n=4 Participants
92 Participants
n=27 Participants
46 Participants
n=483 Participants
174 Participants
n=36 Participants
Age, Categorical
>=65 years
8 Participants
n=93 Participants
13 Participants
n=4 Participants
96 Participants
n=27 Participants
51 Participants
n=483 Participants
168 Participants
n=36 Participants
Sex: Female, Male
Female
12 Participants
n=93 Participants
11 Participants
n=4 Participants
74 Participants
n=27 Participants
33 Participants
n=483 Participants
130 Participants
n=36 Participants
Sex: Female, Male
Male
15 Participants
n=93 Participants
19 Participants
n=4 Participants
114 Participants
n=27 Participants
64 Participants
n=483 Participants
212 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=93 Participants
3 Participants
n=4 Participants
7 Participants
n=27 Participants
6 Participants
n=483 Participants
18 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=93 Participants
25 Participants
n=4 Participants
149 Participants
n=27 Participants
79 Participants
n=483 Participants
278 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
2 Participants
n=4 Participants
32 Participants
n=27 Participants
12 Participants
n=483 Participants
46 Participants
n=36 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Asian
2 Participants
n=93 Participants
5 Participants
n=4 Participants
9 Participants
n=27 Participants
3 Participants
n=483 Participants
19 Participants
n=36 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=93 Participants
0 Participants
n=4 Participants
2 Participants
n=27 Participants
0 Participants
n=483 Participants
3 Participants
n=36 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
1 Participants
n=483 Participants
7 Participants
n=36 Participants
Race (NIH/OMB)
White
23 Participants
n=93 Participants
20 Participants
n=4 Participants
139 Participants
n=27 Participants
80 Participants
n=483 Participants
262 Participants
n=36 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
3 Participants
n=4 Participants
34 Participants
n=27 Participants
13 Participants
n=483 Participants
50 Participants
n=36 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
0 Participants
n=483 Participants
1 Participants
n=36 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months)

Population: Phase 3 Intent-to-Treat Population (Ph3-ITT) consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST version 1.1, 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.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
2.83 Months
Interval 2.73 to 4.11
2.07 Months
Interval 1.51 to 3.06

PRIMARY outcome

Timeframe: From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months)

Population: The Phase 3 Open-Label Population (Ph3-OL) consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=63 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
2.73 Months
Interval 1.97 to 4.14

PRIMARY outcome

Timeframe: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)

Population: The Phase 2 Intent-to-Treat Population (Ph2-ITT) consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.

PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1
3.02 Months
Interval 1.41 to
Data could not be estimated due to higher number (\>50%) of deaths.
2.76 Months
Interval 1.58 to
Data could not be estimated due to higher number (\>50%) of deaths.

PRIMARY outcome

Timeframe: From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)

Population: The Phase 2 Open-Label Population (Ph2-OL) consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered open-label period, and received at least one dose of open-label selinexor.

PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=24 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
1.38 Months
Interval 1.38 to 2.27

SECONDARY outcome

Timeframe: From date of randomization until death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Overall Survival (OS)
10.38 Months
Interval 8.41 to 13.4
12.71 Months
Interval 8.54 to 15.9

SECONDARY outcome

Timeframe: From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=63 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Overall Survival (OS)
10.18 Months
Interval 5.78 to 14.69

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.

OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Overall Survival (OS)
17.31 Months
Interval 10.51 to 29.57
16.07 Months
Interval 8.38 to 23.06

SECONDARY outcome

Timeframe: From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=24 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open Label: Overall Survival (OS)
8.90 Months
Interval 4.96 to 18.92

SECONDARY outcome

Timeframe: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
2.83 Months
Interval 2.73 to 4.11
2.10 Months
Interval 1.51 to 3.06

SECONDARY outcome

Timeframe: From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=63 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
2.73 Months
Interval 1.97 to 4.14

SECONDARY outcome

Timeframe: From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.

TTP was defined as the time from date of randomization until ICR-determined PD as per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
3.02 Months
Interval 1.41 to
Data could not be estimated due to the higher number (\>50%) of deaths.
2.76 Months
Interval 1.58 to
Data could not be estimated due to the higher number (\>50%) of deaths.

SECONDARY outcome

Timeframe: From date of randomization in the Phase 2 open-label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)

Population: The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

TTP was defined as the time from date of randomization in the Phase 2 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=24 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
1.38 Months
Interval 1.38 to 2.27

SECONDARY outcome

Timeframe: From date of randomization until the documentation of CR or PR (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR), per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Overall Response Rate (ORR)
2.7 Percentage of participants
Interval 0.9 to 6.1
0 Percentage of participants
Data could not be evaluated due to no CR or PR events in the placebo arm.

SECONDARY outcome

Timeframe: From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)

Population: The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=63 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Overall Response Rate (ORR)
3.2 Percentage of participants
Interval 0.4 to 11.0

SECONDARY outcome

Timeframe: From date of randomization until the documentation of CR or PR (up to 70 months)

Population: The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.

ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Overall Response Rate (ORR)
0 Percentage of participants
Data could not be evaluated since no participant had CR or PR.
0 Percentage of participants
Data could not be evaluated since no participant had CR or PR.

SECONDARY outcome

Timeframe: From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)

Population: The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. Data could not be evaluated due to no CR or PR events.

ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=24 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open Label: Overall Response Rate (ORR)
Participants who achieved CR
0 Percentage of participants
Phase 2 Open Label: Overall Response Rate (ORR)
Participants who achieved PR
0 Percentage of participants

SECONDARY outcome

Timeframe: From first occurrence of CR or PR until the first date of PD (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. Here, "overall number of participants analyzed" signifies those who had CR and PR in specified group/arm and phase.

DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=5 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Duration of Response (DOR)
7.39 Months
Upper and lower limit of 95% CI was not estimable due to lesser number of participants with events.

SECONDARY outcome

Timeframe: From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

PFS was defined as the time from date of randomization until the first date of PD, per RECIST version 1.1, or death due to any cause as defined by the Investigator based on clinical and/or radiologic criteria. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment
2.89 Months
Interval 2.76 to 4.17
1.87 Months
Interval 1.45 to 2.89

SECONDARY outcome

Timeframe: Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=188 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Time to Next Treatment (TTNT)
5.42 Months
Interval 4.67 to 6.34
3.22 Months
Interval 2.56 to 3.78

SECONDARY outcome

Timeframe: Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)

Population: The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.

TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Time to Next Treatment (TTNT)
4.96 Months
Interval 3.91 to 14.03
2.92 Months
Interval 2.04 to 5.06

SECONDARY outcome

Timeframe: From start of study drug administration up to 70 months

Population: The Phase 3 Safety Population (Ph3-SAF) consisted of all participants in Phase 3 who had received at least one dose of blinded study treatment.

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. A TEAE was defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=187 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with TEAEs
187 Participants
94 Participants
Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Participants with Serious TEAEs
73 Participants
18 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to 70 months

Population: The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=63 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs
Participants with TEAEs
63 Participants
Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs
Participants with Serious TEAEs
25 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to 70 months

Population: The Phase 2 Safety Population (Ph2-SAF) consisted of all participants in Phase 2 who had received at least one dose of blinded study treatment.

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=27 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=30 Participants
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs
Participants with TEAEs
27 Participants
29 Participants
Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs
Participants with Serious TEAEs
4 Participants
6 Participants

SECONDARY outcome

Timeframe: From start of study drug administration up to 70 months

Population: The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered open-label period, and received at least one dose of open-label selinexor.

An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=24 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs
Participants with TEAEs
24 Participants
Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs
Participants with Serious TEAEs
13 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 1387

Population: The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=1 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Global Health Status
33.33 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Physical Functioning
20.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Role Functioning
16.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Emotional Functioning
8.33 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Social Functioning
50.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Cognitive Functioning
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Fatigue
-22.22 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Nausea and Vomiting
16.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Pain
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Dyspnoea
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Insomnia
33.33 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Appetite Loss
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Constipation
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Diarrhoea
33.33 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Financial Difficulties
-66.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.

SECONDARY outcome

Timeframe: Baseline up to Day 379

Population: The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

The QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of patients with cancer. QLQ-C30 contains 30 questions that include five functional scales (physical, role, emotional, social, and cognitive functioning); three symptom scales (fatigue, nausea/vomiting and pain); six single-item symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and global health status/quality of life (QoL). Most questions used a 4-point scale (from 1 'Not at all' to 4 'Very much'); 2 questions used a 7-point scale (from 1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. For the functional scales and the global health status/QoL, a higher score represents a better level of functioning (better health status); for the symptom scales/items, a higher score represents a higher level of symptomatology/problems (worse health status).

Outcome measures

Outcome measures
Measure
Phase 3 Double-blinded: Selinexor
n=1 Participants
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Global Health Status
-16.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Physical Functioning
-40.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Role Functioning
-33.33 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Emotional Functioning
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Social Functioning
-50.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Cognitive Functioning
-16.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Fatigue
66.67 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Nausea and Vomiting
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Pain
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Dyspnoea
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Insomnia
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Appetite Loss
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Constipation
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Diarrhoea
0.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
Financial Difficulties
100.00 Score on a Scale
Standard Deviation NA
Here, "NA" signifies standard deviation was not estimated due to single participant.

Adverse Events

Phase 2 Double-blinded: Selinexor

Serious events: 4 serious events
Other events: 27 other events
Deaths: 18 deaths

Phase 2 Double-blinded: Placebo

Serious events: 6 serious events
Other events: 29 other events
Deaths: 25 deaths

Phase 3 Double-blinded: Selinexor

Serious events: 73 serious events
Other events: 186 other events
Deaths: 127 deaths

Phase 3 Double-blinded: Placebo

Serious events: 18 serious events
Other events: 94 other events
Deaths: 67 deaths

Phase 2 Open-label: Selinexor

Serious events: 13 serious events
Other events: 24 other events
Deaths: 20 deaths

Phase 3 Open-label: Selinexor

Serious events: 25 serious events
Other events: 62 other events
Deaths: 43 deaths

Serious adverse events

Serious adverse events
Measure
Phase 2 Double-blinded: Selinexor
n=27 participants at risk
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double-blinded: Placebo
n=30 participants at risk
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Selinexor
n=187 participants at risk
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 participants at risk
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open-label: Selinexor
n=24 participants at risk
Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Phase 3 Open-label: Selinexor
n=63 participants at risk
Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Blood and lymphatic system disorders
Anaemia
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Cardiac failure
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Cardiac ventricular thrombosis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Atrial fibrillation
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Cardiac arrest
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Large intestine perforation
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Small intestine obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Abdominal pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Nausea
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
4/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Vomiting
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Anastomotic ulcer haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Constipation
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Diarrhoea
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Dysphagia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Enterocutaneous fistula
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Gastritis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Intra-abdominal haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Obstruction gastric
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Rectal obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Stomatitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Ileus
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Fatigue
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Pain
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
General physical health deterioration
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Oedema peripheral
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Pyrexia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Sudden death
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Complication associated with device
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Pneumonia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Bacteraemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Sepsis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Bronchitis viral
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Cellulitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Influenza
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Urinary tract infection
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Device related infection
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Escherichia infection
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Lung abscess
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Peritonitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Pneumonia klebsiella
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Septic shock
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Upper respiratory tract infection
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Bronchitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Fracture
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Fall
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Head injury
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Wound complication
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Injury, poisoning and procedural complications
Facial bones fracture
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Transaminases increased
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Ejection fraction decreased
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Dehydration
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyperglycaemia
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Acute kidney injury
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Haematuria
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Renal failure
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Hydronephrosis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Syncope
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Cerebral ischaemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Cerebrovascular accident
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Dizziness
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Lethargy
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Product Issues
Device breakage
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Mania
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Suicide attempt
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Delirium
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Confusional state
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Venous thrombosis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Deep vein thrombosis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Embolism
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Hepatobiliary disorders
Bile duct obstruction
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Hepatobiliary disorders
Cholangitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Cataract
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Retinal tear
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

Other adverse events

Other adverse events
Measure
Phase 2 Double-blinded: Selinexor
n=27 participants at risk
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Double-blinded: Placebo
n=30 participants at risk
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Selinexor
n=187 participants at risk
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 3 Double-blinded: Placebo
n=97 participants at risk
Participants received a fixed blinding dose of placebo matched to selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Phase 2 Open-label: Selinexor
n=24 participants at risk
Participants in the placebo group who had PD during Phase 2 double-blinded treatment were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Phase 3 Open-label: Selinexor
n=63 participants at risk
Participants in the placebo group who had PD during Phase 3 double-blinded treatment, were entered in open-label and received selinexor 60 mg tablet twice-weekly during Weeks 1 to 6 of each 6-week (42-day) cycle.
Blood and lymphatic system disorders
Anaemia
59.3%
16/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
30.0%
9/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
48.7%
91/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
22.7%
22/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
41.7%
10/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
41.3%
26/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Blood and lymphatic system disorders
Thrombocytopenia
40.7%
11/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
38.5%
72/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
45.8%
11/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
38.1%
24/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Blood and lymphatic system disorders
Leukopenia
33.3%
9/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.9%
26/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.8%
5/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.6%
13/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Blood and lymphatic system disorders
Neutropenia
29.6%
8/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.3%
38/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
25.0%
6/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
19.0%
12/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.5%
14/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.1%
4/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.5%
6/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Sinus Tachycardia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.2%
6/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.5%
6/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Cardiac disorders
Tachycardia
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Ear and labyrinth disorders
Vertigo
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
4/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Vision Blurred
29.6%
8/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
22.5%
42/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
37.5%
9/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.7%
8/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Cataract
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Photopsia
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
9/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Visual Impairement
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.3%
10/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Eye disorders
Vitreous floaters
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Nausea
88.9%
24/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
33.3%
10/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
80.7%
151/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
39.2%
38/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
83.3%
20/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
71.4%
45/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Vomiting
55.6%
15/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.3%
4/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
49.7%
93/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.4%
12/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
58.3%
14/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
49.2%
31/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Abdominal pain
22.2%
6/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
26.7%
8/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
26.2%
49/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
30.9%
30/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.8%
5/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.6%
13/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Constipation
22.2%
6/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
26.7%
8/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
39.6%
74/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
23.7%
23/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
25.0%
6/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
22.2%
14/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Diarrhoea
29.6%
8/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
5/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
40.1%
75/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
17.5%
17/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
29.2%
7/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
28.6%
18/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Abdominal distension
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.2%
6/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Flatulence
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.3%
10/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Dry mouth
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Dyspepsia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.6%
18/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.2%
6/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Gastrointestinal disorders
Gastroesophageal reflux disease
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Fatigue
55.6%
15/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
46.7%
14/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
51.3%
96/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
32.0%
31/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
75.0%
18/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
52.4%
33/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Oedema peripheral
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.0%
30/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.4%
12/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
15.9%
10/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Pyrexia
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.3%
4/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.7%
20/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.3%
9/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.7%
8/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Influenza like illness
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Malaise
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Chills
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.2%
7/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Pain
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
4/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Non-cardiac chest pain
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
Asthenia
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
31.0%
58/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.3%
10/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.6%
13/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
General disorders
General physical health deterioration
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Hepatobiliary disorders
Hyperbilirubinaemia
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Urinary tract infection
18.5%
5/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.0%
13/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.2%
8/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Rhinitis
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Infections and infestations
Sinusitis
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Weight decreased
51.9%
14/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
43.3%
81/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.3%
9/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
62.5%
15/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
39.7%
25/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Blood alkaline phosphatase increased
22.2%
6/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
23.3%
7/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.5%
14/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.3%
10/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Alanine aminotransferase increased
22.2%
6/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.6%
16/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.5%
6/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Aspartate aminotransferase increased
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.3%
4/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
4/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Electrocardiogram QT prolonged
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
International normalised ratio increased
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Investigations
Blood lactate dehydrogenase increased
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Decreased appetite
55.6%
15/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
5/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
77.0%
144/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
21.6%
21/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
58.3%
14/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
50.8%
32/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyponatraemia
33.3%
9/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
20.0%
6/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
27.8%
52/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.2%
8/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
41.7%
10/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
17.5%
11/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyperglycaemia
33.3%
9/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.2%
21/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.2%
8/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypercreatininaemia
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
5/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
22.5%
42/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.4%
13/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
29.2%
7/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
14.3%
9/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypoalbuminaemia
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
5/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.3%
10/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.2%
8/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypokalaemia
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.3%
4/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.7%
20/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypomagnesaemia
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.8%
24/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypocalcaemia
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.3%
8/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.1%
4/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.0%
13/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
4/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Dehydration
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypochloraemia
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hypophosphataemia
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.0%
13/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Metabolism and nutrition disorders
Hyperuricaemia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Back pain
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
13.9%
26/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.4%
12/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
4/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Arthralgia
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
9/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Muscular weakness
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
9/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.2%
7/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Muscle spasms
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.4%
12/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Musculoskeletal and connective tissue disorders
Pain in extremity
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.1%
4/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Dysgeusia
37.0%
10/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
27.3%
51/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.1%
4/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
25.0%
6/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
19.0%
12/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Dizziness
25.9%
7/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
24.1%
45/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.2%
6/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.7%
4/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
17.5%
11/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Headache
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.3%
23/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Taste disorder
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.3%
8/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Sciatica
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Nervous system disorders
Syncope
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Insomnia
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.2%
21/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.1%
4/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
2/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Anxiety
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Depression
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.9%
11/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.1%
2/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Psychiatric disorders
Confusional state
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Haematuria
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.2%
7/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Micturition urgency
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.53%
1/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Renal and urinary disorders
Pollakiuria
7.4%
2/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Cough
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
16.0%
30/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.2%
7/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
29.2%
7/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.1%
7/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Epistaxis
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.3%
1/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.2%
6/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
29.2%
7/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
15.9%
10/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
3.7%
1/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.7%
7/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.0%
1/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
1/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.7%
2/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.1%
2/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.8%
3/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Skin and subcutaneous tissue disorders
Night sweats
11.1%
3/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.0%
13/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
2.7%
5/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
5.2%
5/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
8.3%
2/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Hypertension
18.5%
5/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
11.8%
22/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.3%
10/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
9.5%
6/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Hypotension
14.8%
4/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
10.0%
3/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.3%
23/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
12.5%
3/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
7.9%
5/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
Vascular disorders
Hot flush
0.00%
0/27 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
0.00%
0/30 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
1.6%
3/187 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
3.1%
3/97 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
4.2%
1/24 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
6.3%
4/63 • From start of study drug administration up to 70 months
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.

Additional Information

Karyopharm Medical Information

Karyopharm Therapeutics Inc

Phone: (888) 209-9326

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER