Selinexor in Advanced Liposarcoma | NCT02606461 | Trialant
NCT02606461
Sponsor
Karyopharm Therapeutics Inc
Status
Completed
Last Update Posted
Jan 23, 2023Actual
Enrollment
342Actual
Phase
Phase 2Phase 3
Conditions
Dedifferentiated Liposarcoma
Interventions
Selinexor
Placebo
Countries
United States
Belgium
Canada
France
Germany
Israel
Italy
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02606461
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KCP-330-020
Secondary IDs
ID
Type
Description
Link
2015-003594-14
EudraCT Number
Brief Title
Selinexor in Advanced Liposarcoma
Official Title
A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)
Acronym
SEAL
Organization
Karyopharm Therapeutics IncINDUSTRY
Status Module
Record Verification Date
Jan 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 4, 2016Actual
Primary Completion Date
Oct 28, 2020Actual
Completion Date
Oct 26, 2021Actual
First Submitted Date
Oct 13, 2015
First Submission Date that Met QC Criteria
Nov 13, 2015
First Posted Date
Nov 17, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 8, 2021
Results First Submitted that Met QC Criteria
Nov 8, 2021
Results First Posted Date
Dec 7, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 5, 2023
Last Update Posted Date
Jan 23, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Karyopharm Therapeutics IncINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).
Detailed Description
In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.
In the Phase 3 portion of the study, approximately 285 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.
Patients who progress during the blinded portion of the study will be unblinded and if receiving:
placebo, may cross over to open-label selinexor (60mg twice-weekly)
selinexor, will be withdrawn from further treatment and followed for survival
Study treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.
Treatment will continue until one or more of the following occurs:
Disease progression, as defined by RECIST v1.1 Response Criteria
Clinical progression, as determined by the treating physician
Unacceptable adverse events (AEs) or failure to tolerate study treatment
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 until progressive disease (PD).
Drug: Selinexor
Phase 3 Double-blinded: Selinexor
Experimental
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle until PD.
Drug: Selinexor
Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor
Placebo Comparator
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 until PD in double-blinded treatment period. Participants in the placebo group who had PD during the Phase 2 double-blinded treatment, will be elected to cross over to open-label selinexor.
Drug: Placebo
Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor
Placebo Comparator
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 until PD or development of unacceptable toxicity. Participants in the placebo group who had PD during the Phase 3 double-blinded treatment, will be elected to cross over to open-label selinexor.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Selinexor
Drug
Selinexor 60mg
Phase 2 Double-blinded: Selinexor
Phase 3 Double-blinded: Selinexor
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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.
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)
Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
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)
Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)
Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
Secondary Outcomes
Measure
Description
Time Frame
Phase 3 Double Blind: Overall Survival (OS)
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.
From date of randomization until death due to any cause, whichever occurred first (up to 70 months)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients ≥12 years of age
Body surface area (BSA) ≥ 1.2 m2
Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
Must have measurable disease per RECIST v1.1 Response Criteria
Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug, whichever is shorter) with all clinically significant therapy-related toxicities having resolved to ≤ Grade 1
Exclusion Criteria:
Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or pleomorphic tumor histologic subtypes
Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection
Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Groschel S, Hatcher H, Duffaud F, Herraez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Gotze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. doi: 10.1200/JCO.21.01829. Epub 2022 Apr 8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
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.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
Phase 2 Double-blinded: Placebo
Periods
Title
Milestones
Reasons Not Completed
Period 1: Double-blinded Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 21, 2020
Oct 22, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
KPT-330
Placebo
Drug
Phase 2 Double-blinded: Placebo Followed by Open Label- Selinexor
Phase 3 Double-blinded: Placebo Followed by Open Label- Selinexor
sugar pill
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)
Phase 3 Open Label: Overall Survival (OS)
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.
From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months)
Phase 2 Double Blind: Overall Survival (OS)
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.
From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)
Phase 2 Open Label: Overall Survival (OS)
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.
From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months)
Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)
Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
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)
Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)
Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
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)
Phase 3 Double Blind: Overall Response Rate (ORR)
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.
From date of randomization until the documentation of CR or PR (up to 70 months)
Phase 3 Open Label: Overall Response Rate (ORR)
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.
From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)
Phase 2 Double Blind: Overall Response Rate (ORR)
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.
From date of randomization until the documentation of CR or PR (up to 70 months)
Phase 2 Open Label: Overall Response Rate (ORR)
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.
From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)
Phase 3 Double Blind: Duration of Response (DOR)
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.
From first occurrence of CR or PR until the first date of PD (up to 70 months)
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment
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.
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)
Phase 3 Double Blind: Time to Next Treatment (TTNT)
TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)
Phase 2 Double Blind: Time to Next Treatment (TTNT)
TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)
Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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.
From start of study drug administration up to 70 months
Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs
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.
From start of study drug administration up to 70 months
Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs
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.
From start of study drug administration up to 70 months
Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs
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.
From start of study drug administration up to 70 months
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
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).
Baseline up to Day 1387
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
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).
Technische Universitaet Dresden Med. Fakultaet Carl Gustav Carus Med. Klinik u. Poliklinik I
Dresden
01307
Germany
National Center for Tumor Diseases, Univeristy Hospital Heidelberg
Heidelberg
69120
Germany
University Hospital Mannheim
Mannheim
68167
Germany
Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen
München
81675
Germany
Soroka University Medical Center
Beersheba
84101
Israel
Hadassah Medical Center
Jerusalem
91120
Israel
Rabin Medical Center
Petah Tikva
4941492
Israel
Sheba Medical Center
Ramat Gan
52621
Israel
Tel Aviv Sourasky Medical
Tel Aviv
64239
Israel
Assaf Harofe Medical Center
Ẕerifin
7030000
Israel
Candiolo Cancer Institute
Candiolo
10060
Italy
Istituto Nazionale dei Tumori, Milan
Milan
20133
Italy
U.O.C. Oncologia Medica Oncology Department
Palermo
90127
Italy
Policlinico Universitario Campus Biomedico
Roma
00128
Italy
"Germans Trias Pujol" University Hospital
Badalona
41013
Spain
Vall d´hebron University Hospital
Barcelona
08035
Spain
Hospital Sant Pau Barcelona
Barcelona
08041
Spain
Hospital ICO Bellvitge
Barcelona
08908
Spain
Hospital Universitario ClÃnico San Carlos
Madrid
28040
Spain
Hospital Universitario Virgen Del Rocio
Seville
41013
Spain
Hospital La Fe Valencia
Valencia
46026
Spain
Sahlgrenska Universitetssjukhuset
Gothenburg
413 45
Sweden
Skane University Hospital
Lund
221 85
Sweden
Onkologiska Kliniken
Stockholm
171 76
Sweden
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom
University College London Hospitals
London
NW1 2BU
United Kingdom
The Royal Marsden NHS Foundation Trust
London
SW3 6JJ
United Kingdom
The Christie
Manchester
M20 4BX
United Kingdom
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG00027 subjects
FG00130 subjects
FG002188 subjects
FG00397 subjects
FG0040 subjects
FG0050 subjects
Treated
FG00027 subjects
FG00130 subjects
FG002187 subjects
FG00397 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00027 subjects
FG00130 subjects
FG002187 subjects
FG00397 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Randomized but no treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Period 2: Open Label Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00424 subjectsParticipants in the placebo group who had PD during the Phase 2 double-blinded treatment, switched to open-label selinexor.
FG00563 subjectsParticipants in the placebo group who had PD during the Phase 3 double-blinded treatment, switched to open-label selinexor.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 2 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.
BG001
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.
BG002
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.
BG003
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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00130
BG002188
BG00397
BG004342
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000188
OG00197
Title
Denominators
Categories
Title
Measurements
OG0002.83(2.73 to 4.11)
OG0012.07(1.51 to 3.06)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0114
Hazard Ratio (HR)
0.7026
2-Sided
95
0.5191
0.9509
Superiority
Primary
Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Primary
Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months)
ID
Title
Description
OG000
Phase 2 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.
OG001
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.
Units
Counts
Participants
Primary
Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 3 Double Blind: Overall Survival (OS)
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.
The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
From date of randomization until death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
Secondary
Phase 3 Open Label: Overall Survival (OS)
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.
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.
Posted
Median
95% Confidence Interval
Months
From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 2 Double Blind: Overall Survival (OS)
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.
The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
From the date of randomization until death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
Phase 2 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.
OG001
Phase 2 Double-blinded: Placebo
Participants received a fixed blinding dose of 60 mg selinexor twice-weekly on Day 1 and 3 during each 6-week (42-day) cycle.
Units
Counts
Participants
Secondary
Phase 2 Open Label: Overall Survival (OS)
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.
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.
Posted
Median
95% Confidence Interval
Months
From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
Secondary
Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months)
ID
Title
Description
OG000
Phase 2 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.
OG001
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.
Units
Counts
Participants
Secondary
Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1
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.
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.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 3 Double Blind: Overall Response Rate (ORR)
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.
The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From date of randomization until the documentation of CR or PR (up to 70 months)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Secondary
Phase 3 Open Label: Overall Response Rate (ORR)
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.
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.
Posted
Number
95% Confidence Interval
Percentage of participants
From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 2 Double Blind: Overall Response Rate (ORR)
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.
The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From date of randomization until the documentation of CR or PR (up to 70 months)
ID
Title
Description
OG000
Phase 2 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.
OG001
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.
Units
Counts
Participants
Secondary
Phase 2 Open Label: Overall Response Rate (ORR)
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.
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.
Posted
Number
Percentage of participants
From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG000
Secondary
Phase 3 Double Blind: Duration of Response (DOR)
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.
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.
Posted
Number
95% Confidence Interval
Months
From first occurrence of CR or PR until the first date of PD (up to 70 months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment
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.
The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
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)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Secondary
Phase 3 Double Blind: Time to Next Treatment (TTNT)
TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)
ID
Title
Description
OG000
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.
OG001
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.
Units
Counts
Participants
OG000
Secondary
Phase 2 Double Blind: Time to Next Treatment (TTNT)
TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first.
The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment.
Posted
Median
95% Confidence Interval
Months
Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months)
ID
Title
Description
OG000
Phase 2 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.
OG001
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.
Units
Counts
Participants
OG000
Secondary
Phase 3 Double Blind: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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.
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.
Posted
Count of Participants
Participants
From start of study drug administration up to 70 months
ID
Title
Description
OG000
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.
OG001
Phase 3 Double-blinded: Placebo
Secondary
Phase 3 Open Label: Number of Participants With TEAEs and Serious TEAEs
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.
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.
Posted
Count of Participants
Participants
From start of study drug administration up to 70 months
ID
Title
Description
OG000
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.
Secondary
Phase 2 Double Blind: Number of Participants With TEAEs and Serious TEAEs
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.
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.
Posted
Count of Participants
Participants
From start of study drug administration up to 70 months
ID
Title
Description
OG000
Phase 2 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.
OG001
Phase 2 Double-blinded: Placebo
Secondary
Phase 2 Open Label: Number of Participants With TEAEs and Serious TEAEs
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.
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.
Posted
Count of Participants
Participants
From start of study drug administration up to 70 months
ID
Title
Description
OG000
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.
Secondary
Phase 3 Double Blind: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
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).
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.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline up to Day 1387
ID
Title
Description
OG000
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.
OG001
Phase 3 Double-blinded: Placebo
Secondary
Phase 3 Open Label: Change From Baseline in Quality-of-life Questionnaire 30 Item (QLQ-C30)
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).
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.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline up to Day 379
ID
Title
Description
OG000
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.
Time Frame
From start of study drug administration up to 70 months
Description
The Ph2-SAF and Ph3-SA consisted of all participants who had received at least one dose of blinded study treatment in Phase 2 and Phase 3 respectively. The Phase 3 open-label population (Ph3-OL) and Phase 2 open-label Population (Ph2-OL) consisted of all participants in Phase 3 and Phase 2 respectively, who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 2 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.
18
27
4
27
27
27
EG001
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.
25
30
6
30
29
30
EG002
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.
127
187
73
187
186
187
EG003
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.
67
97
18
97
94
97
EG004
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.
20
24
13
24
24
24
EG005
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.
43
63
25
63
62
63
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected30 at risk
EG0023 affected187 at risk
EG0030 affected97 at risk
EG0041 affected24 at risk
EG0052 affected63 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0022 affected187 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0020 affected187 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0020 affected187 at risk
EG003
Small intestine obstruction
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0022 affected187 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0027 affected187 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0024 affected187 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Anastomotic ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Enterocutaneous fistula
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Rectal obstruction
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0021 affected187 at risk
EG003
Pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Sudden death
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Complication associated with device
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0012 affected30 at risk
EG0023 affected187 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0020 affected187 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0020 affected187 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Anastomotic ulcer haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0011 affected30 at risk
EG0023 affected187 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0020 affected187 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0021 affected187 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 affected27 at risk
EG0010 affected30 at risk
EG0022 affected187 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)