Selinexor in Initial or Refractory and/or Relapsed Richte... | NCT02138786

NCT02138786

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
selinexor	Experimental	oral tablets 10 mg & 25 mg (bottled); or 20 mg (blister pack)	Drug: selinexor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
selinexor	Drug	60 mg dose twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle; dose may be increased to 80 mg after Cycle 1 unless clinically contraindicated (Protocol V.5.0). 60 mg dose twice weekly on Days 1 and 3 of weeks 1-3 of each 4-week cycle; dose may be increased to 80 mg at Cycle 3 Day 1 unless clinically contraindicated (Protocol V.4.0). 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-3 of each 4-week cycle (Protocol V. 3.0). 60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle (Protocol V. < 3.0).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Overall Response (Overall Response Rate)	Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.	Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Number of Participants With Complete Response (CR)	Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.	Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Number of Participants With Partial Response (PR)	Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.	Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Disease Control (Disease Control Rate)	Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona Cancer Center		Tucson	Arizona	85724	United States
City of Hope National Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17242396	Background	Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Selinexor 60 mg/m² (8 Doses/Cycle)	60 mg/m² dose twice weekly for weeks 1-4
FG001	Selinexor 60 mg (6 Doses/Cycle)	60 mg oral dose twice weekly for weeks 1-3

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Safety Population, consisting of all patients who received any amount of study medication.

Arm/Group Information

ID	Title	Description
BG000	Selinexor 60 mg/m² (8 Doses/Cycle)	60 mg/m² oral dose twice weekly for Weeks 1-4
BG001	Selinexor 60 mg (6 Doses/Cycle)	60 mg oral dose twice weekly for Weeks 1-3
BG002	Selinexor 60 mg (8 Doses/Cycle)	60 mg oral dose twice weekly for Weeks 1-4
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG00115 BG0028 BG00326

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00068.0(66 to 74) BG00168.0(41 to 77) BG00269.0(65 to 79) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

ECOG score

Performance Status as measured by Eastern Cooperative Oncology Group (ECOG) Status Scale:

Score=0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

Score=1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

Score=2: In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Score=0	BG0000 BG001

Weight

kilograms

Median

Full Range

Title

Denominators

Categories

Title	Measurements
	BG00056.5(52.3 to 96.0) BG00176.5(51.9 to 115.5) 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

Percentage of Participants With Overall Response (Overall Response Rate)

Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.

Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.

Posted

Number

95% Confidence Interval

Percentage of participants

Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants	OG00025

Title

Denominators

Categories

Title	Measurements
	OG0004(0.1 to 20.4)

Primary

Number of Participants With Complete Response (CR)

Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants

Primary

Number of Participants With Partial Response (PR)

Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants

Primary

Number of Participants With Stable Disease (SD)

Number of patients whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants

Primary

Number of Participants With Progressive Disease (PD)

Number of patients whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants

Primary

Number of Participants With Not Evaluable (NE) Response

Number of patients who could not be assessed quantitatively for disease response for any reason.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Disease Control (Disease Control Rate)

Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Number

95% Confidence Interval

Percentage of participants

ID	Title	Description
OG000	Selinexor	All dosing groups

Units

Secondary

Duration of Progression Free Survival (PFS)

Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Patients who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Patients without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

Posted

Median

95% Confidence Interval

Days

ID	Title	Description
OG000	Selinexor	All dosing groups

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	Selinexor 60 mg/m² (8 Doses/Cycle)	60 mg/m² oral dose twice weekly for Weeks 1-4	1	3	3	3	3	3
EG001	Selinexor 60 mg (6 Doses/Cycle)	60 mg oral dose twice weekly for Weeks 1-3	8	15	9	15	15	15
EG002	Selinexor 60 mg (8 Doses/Cycle)	60 mg oral dose twice weekly for Weeks 1-4	2	8	5	8	7	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0022 affected8 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
General Physical Health Deterioration	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Mucosal Inflammation	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Food Intolerance	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Embolism Arterial	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Clostridium Test Positive	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Tumour Haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected3 at risk EG0018 affected15 at risk EG0023 affected8 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0015 affected15 at risk EG0023 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0017 affected15 at risk EG0021 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected15 at risk EG0022 affected8 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Anal Incontinence	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Tongue Coated	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0016 affected15 at risk EG0022 affected8 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected3 at risk EG0014 affected15 at risk EG0022 affected8 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0014 affected15 at risk EG0022 affected8 at risk
Oedema Peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0015 affected15 at risk EG0021 affected8 at risk
General Physical Health Deterioration	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Mucosal Inflammation	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Early Satiety	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Facial Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Oedema	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0018 affected15 at risk EG0025 affected8 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0015 affected15 at risk EG0021 affected8 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected15 at risk EG0023 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected15 at risk EG0022 affected8 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected3 at risk EG0015 affected15 at risk EG0022 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0014 affected15 at risk EG0022 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0023 affected8 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0022 affected8 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0021 affected8 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0021 affected8 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Oral Candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0022 affected8 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Oral Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Bacteriuria	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Device Related Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Herpes Ophthalmic	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Oral Herpes	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0014 affected15 at risk EG0020 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0022 affected8 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0024 affected8 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0013 affected15 at risk EG0020 affected8 at risk
Dysgeusia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Aphasia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Ataxia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Horner's Syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Hypokinesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Lethargy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Migraine With Aura	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Nervous System Disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Visual Field Defect	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected3 at risk EG0010 affected15 at risk EG0022 affected8 at risk
Haematoma	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Embolism	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Haemorrhage	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Hot Flush	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Pallor	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Phlebitis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Post Procedural Contusion	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0012 affected15 at risk EG0021 affected8 at risk
Weight Decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0023 affected8 at risk
C-Reactive Protein Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Blood Creatinine Phophokinase Decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Blood Creatinine Phosphokinase Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Hypophonesis	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
International Normalised Ratio Increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Protein Total Decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0023 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0021 affected8 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0021 affected8 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Incontinence	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Renal Failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Eye Irritation	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Ocular Toxicity	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Photophobia	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Vision Blurred	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Skin Discolouration	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Skain Abrasion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0022 affected8 at risk
Tumour Associated Fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Deafness	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0012 affected15 at risk EG0020 affected8 at risk
Jaundice	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Confusional State	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0010 affected15 at risk EG0021 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected3 at risk EG0010 affected15 at risk EG0020 affected8 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Oedema Genital	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected3 at risk EG0011 affected15 at risk EG0020 affected8 at risk

The low number of formal objective responses (leading to the termination of the study following the first stage), coupled with the high number of censored observations, limited meaningful analyses and the ability to draw conclusions from the data.

Certain Agreements

ID	Term
C585161	selinexor

BG00374.40(46.4 to 115.5)