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.
COMPLETED
PHASE2/PHASE3
342 participants
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)
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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 1387Population: 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
| 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 379Population: 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
| 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
Phase 2 Double-blinded: Placebo
Phase 3 Double-blinded: Selinexor
Phase 3 Double-blinded: Placebo
Phase 2 Open-label: Selinexor
Phase 3 Open-label: Selinexor
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER