Safety Study of the Selective Inhibitor of Nuclear Export... | NCT01607892

Label	Type	Description	Intervention Names
selinexor	Experimental		Drug: KPT-330

Name	Type	Description	Arm Group Labels	Other Names
KPT-330	Drug		selinexor	Selinexor

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.	From first dose of study drug administration to end of treatment (up to 27 months)
Recommended Phase 2 Dose (RP2D) of Selinexor	Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which > 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was >25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.	From first dose of study drug administration to end of treatment (up to 27 months)

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Selinexor	Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.	0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
Time to Maximum Observed Concentration (Tmax) of Selinexor

Facility	Status	City	State	ZIP	Country	Contacts
Moffitt Cancer Center		Tampa	Florida	33612	United States
Dana-Farber Cancer Institute

PubMed Identifier	Type	Citation	Retractions
29203585	Derived	Chen C, Siegel D, Gutierrez M, Jacoby M, Hofmeister CC, Gabrail N, Baz R, Mau-Sorensen M, Berdeja JG, Savona M, Savoie L, Trudel S, Areethamsirikul N, Unger TJ, Rashal T, Hanke T, Kauffman M, Shacham S, Reece D. Safety and efficacy of selinexor in relapsed or refractory multiple myeloma and Waldenstrom macroglobulinemia. Blood. 2018 Feb 22;131(8):855-863. doi: 10.1182/blood-2017-08-797886. Epub 2017 Dec 4.
28468797

ID	Title	Description
FG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

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

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment.

Safety population consisted of all participants who received at least 1 dose of selinexor.

Posted

Count of Participants

Participants

From first dose of study drug administration to end of treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
OG001	Non-Hodgkin Lymphoma (NHL) Excluding DLBCL	Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
OG002	Multiple Myeloma (MM)	Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
OG003	Acute Myeloid Leukemia (AML)	Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
OG004	Other Hematological Malignancies (ALL, CML and CLL)	Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.

Units	Counts
Participants	OG00058 OG00127 OG00281 OG003

Title

Denominators

Categories

At Least One TEAE

Title	Measurements
	OG00058 OG00127 OG00281 OG003

Primary

Recommended Phase 2 Dose (RP2D) of Selinexor

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which > 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was >25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose.

Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure.

Posted

Number

milligram per square meter (mg/m^2)

From first dose of study drug administration to end of treatment (up to 27 months)

ID	Title	Description
OG000	Advanced Hematological Malignancies.	Participants received selinexor doses of <= 12 mg/m^2, post oral for all cycles 3 times weekly for Weeks 1 and 3 in schedule 1; >12 mg/m^2 3 times weekly for Weeks 2 and 4 in schedule 2; >=30 mg/m^2 on Day 1 and 3 in schedule 3; >= 23 mg/m^2 on Day 1 and Day 2 for a 28-day cycle in schedule 4; >= 30 mg/m^2 on Day 1 and 4 in schedule 5; >= 35 mg/m^2 combined with dexamethasone 20 mg on Day 1 and 3 in schedule 6; >= 45 mg/m^2 once-weekly in schedule 7; >= 40 mg/m^2 twice-weekly for first 2 weeks on Days 1, 3, 8, and 10 followed by an 11-day treatment-free interval in schedule 8; >= 30 mg/m^2 twice weekly for 3 weeks in 28-day cycle followed by fixed dose of 375 mg/m^2 Rituximab in schedule 9; 55 mg/m^2 twice-weekly on Days 1, 3, 8, and 10 followed by 18-day treatment-free interval in schedule 10; 40, 60, 80 mg (group A, group B, group C) twice weekly during the first 3 weeks, on Days 1, 3, 8, 10, 15 and 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.

Secondary

Maximum Observed Plasma Concentration (Cmax) of Selinexor

Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.

Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Time to Maximum Observed Concentration (Tmax) of Selinexor

Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.

PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.

Posted

Median

Full Range

hour

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor

Cavg0-24h was defined as average concentration from time 0 to 24 hours.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor

AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram* hours per milliliter

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor

AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated).

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor

Apparent volume of distribution was calculated as Dose/ (kel *AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram [kg]).

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per kilogram (L/kg)

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor

Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg).

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour per kilogram (L/h/kg)

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Terminal Half-Life (t½) of Selinexor

t½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve.

Posted

Median

Full Range

hour

0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2

ID	Title	Description
OG000	Selinexor (3 mg/m^2)	Participants received selinexor dose of 3 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG001	Selinexor (6 mg/m^2)	Participants received selinexor dose of 6 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
OG002	Selinexor (12 mg/m^2)	Participants received selinexor dose of 12 mg/m^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.

Secondary

Number of Participants With Overall Response of Selinexor

Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).

Efficacy analysis included all participants registered to the study who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity.

Posted

Number

participants

From first dose of study drug administration to end of treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

Secondary

Duration of Response

Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.

Efficacy analysis included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented disease progression, death related to disease, or treatment-related toxicity. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.

Posted

Median

95% Confidence Interval

Days

From first dose of study drug administration to end of treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

Secondary

Progression-free Survival

Progression-free survival (PFS) was calculated from the date of first dose of study drug to first documented evidence of disease recurrence or progression or death due to any cause. Participants who were last known to be alive and without evidence of progression were censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.

Posted

Median

95% Confidence Interval

Days

Cycle 1 Day 1 to End of Treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

Secondary

Duration of at Least Stable Disease

Duration of at least stable disease was defined as the time from the date of first dose of study drug to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment.

Posted

Median

95% Confidence Interval

Days

Cycle 1 Day 1 to End of Treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

Secondary

Overall Survival

Overall Survival was calculated from the date of first dose of study drug to date of death due to any cause. Participants who were last known to be alive were censored at time of last contact. Overall survival was calculated by Kaplan-Meier method.

Posted

Median

95% Confidence Interval

Days

Cycle 1 Day 1 to End of Treatment (up to 27 months)

ID	Title	Description
OG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Embolism	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG0032 affected95 at risk EG0040 affected24 at risk
Hypotension	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Small intestinal resection	Surgical and medical procedures	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected27 at risk EG0025 affected81 at risk EG003
Fatigue	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Death	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Asthenia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Disease progression	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Gait disturbance	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Pain	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Performance status decreased	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Sudden death	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Unevaluable event	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Confusional state	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Delirium	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Blood alkaline phosphatase increased	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Palpitations	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0011 affected27 at risk EG0026 affected81 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0024 affected81 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Hyperviscosity syndrome	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Leukostasis syndrome	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Central nervous system haemorrhage	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Seizure	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Encephalitis toxic	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Lethargy	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Somnolence	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Syncope	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Cataract	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Retinal detachment	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Vision blurred	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Vitreous detachment	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0024 affected81 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0023 affected81 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0022 affected81 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Headache	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pneumonia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0028 affected81 at risk EG003
Sepsis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0022 affected81 at risk EG003
Lung infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected27 at risk EG0021 affected81 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Appendicitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Cellulitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Device related infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Epiglottitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Localised infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Mastoiditis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Mucormycosis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Sinusitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Skin infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Urosepsis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypotension	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected58 at risk EG0015 affected27 at risk EG0029 affected81 at risk EG00319 affected95 at risk EG0042 affected24 at risk
Hypertension	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Hot flush	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0012 affected27 at risk EG0020 affected81 at risk EG003
Fatigue	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00039 affected58 at risk EG00113 affected27 at risk EG00262 affected81 at risk EG003
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00021 affected58 at risk EG0014 affected27 at risk EG00222 affected81 at risk EG003
Oedema peripheral	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00013 affected58 at risk EG0012 affected27 at risk EG0028 affected81 at risk EG003
Asthenia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0014 affected27 at risk EG00214 affected81 at risk EG003
Chills	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0015 affected27 at risk EG0027 affected81 at risk EG003
Gait disturbance	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0011 affected27 at risk EG0027 affected81 at risk EG003
Malaise	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0012 affected27 at risk EG0025 affected81 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected27 at risk EG0028 affected81 at risk EG003
Oedema	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Peripheral swelling	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 affected58 at risk EG0018 affected27 at risk EG00215 affected81 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 affected58 at risk EG0014 affected27 at risk EG0028 affected81 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected58 at risk EG0010 affected27 at risk EG0024 affected81 at risk EG003
Depression	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected27 at risk EG0026 affected81 at risk EG003
Agitation	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0010 affected27 at risk EG0026 affected81 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0012 affected27 at risk EG0028 affected81 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected27 at risk EG0026 affected81 at risk EG003
Weight decreased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG00014 affected58 at risk EG00110 affected27 at risk EG00232 affected81 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected58 at risk EG0012 affected27 at risk EG0028 affected81 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0011 affected27 at risk EG0027 affected81 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
International normalised ratio increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0023 affected81 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0024 affected81 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Palpitations	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 affected58 at risk EG0018 affected27 at risk EG00220 affected81 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 affected58 at risk EG0016 affected27 at risk EG00218 affected81 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0011 affected27 at risk EG00216 affected81 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0015 affected27 at risk EG0021 affected81 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0013 affected27 at risk EG0022 affected81 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0010 affected27 at risk EG0023 affected81 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0021 affected81 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00039 affected58 at risk EG00115 affected27 at risk EG00252 affected81 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00034 affected58 at risk EG00114 affected27 at risk EG00242 affected81 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00023 affected58 at risk EG00112 affected27 at risk EG00231 affected81 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00011 affected58 at risk EG0015 affected27 at risk EG00211 affected81 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0012 affected27 at risk EG0027 affected81 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00013 affected58 at risk EG0016 affected27 at risk EG00216 affected81 at risk EG003
Dizziness	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00014 affected58 at risk EG0015 affected27 at risk EG00213 affected81 at risk EG003
Headache	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected58 at risk EG0014 affected27 at risk EG00211 affected81 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0024 affected81 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0012 affected27 at risk EG0022 affected81 at risk EG003
Syncope	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0025 affected81 at risk EG003
Amnesia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected27 at risk EG0022 affected81 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0020 affected81 at risk EG003
Vision blurred	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 affected58 at risk EG0014 affected27 at risk EG00221 affected81 at risk EG003
Cataract	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0026 affected81 at risk EG003
Visual impairment	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
Photopsia	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0025 affected81 at risk EG003
Dry eye	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Eye pain	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0013 affected27 at risk EG0020 affected81 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0022 affected81 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0021 affected81 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00038 affected58 at risk EG00118 affected27 at risk EG00264 affected81 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00025 affected58 at risk EG00111 affected27 at risk EG00240 affected81 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00024 affected58 at risk EG0019 affected27 at risk EG00232 affected81 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 affected58 at risk EG0019 affected27 at risk EG00215 affected81 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00011 affected58 at risk EG0013 affected27 at risk EG0029 affected81 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 affected58 at risk EG0012 affected27 at risk EG0029 affected81 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0011 affected27 at risk EG0021 affected81 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0025 affected81 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0023 affected81 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0025 affected81 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected27 at risk EG0024 affected81 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected58 at risk EG0013 affected27 at risk EG0022 affected81 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0022 affected81 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0010 affected27 at risk EG0020 affected81 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0024 affected81 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0012 affected27 at risk EG0026 affected81 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0013 affected27 at risk EG0027 affected81 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0025 affected81 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0025 affected81 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00012 affected58 at risk EG0012 affected27 at risk EG00219 affected81 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0009 affected58 at risk EG0014 affected27 at risk EG00213 affected81 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0011 affected27 at risk EG0027 affected81 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0012 affected27 at risk EG0026 affected81 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0012 affected27 at risk EG0025 affected81 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0011 affected27 at risk EG0026 affected81 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0012 affected27 at risk EG0025 affected81 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected27 at risk EG0022 affected81 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0021 affected81 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00034 affected58 at risk EG00116 affected27 at risk EG00254 affected81 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00025 affected58 at risk EG0017 affected27 at risk EG00236 affected81 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00014 affected58 at risk EG0015 affected27 at risk EG00212 affected81 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0007 affected58 at risk EG0014 affected27 at risk EG00227 affected81 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00010 affected58 at risk EG0010 affected27 at risk EG00223 affected81 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00014 affected58 at risk EG0014 affected27 at risk EG0026 affected81 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 affected58 at risk EG0017 affected27 at risk EG0026 affected81 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0016 affected27 at risk EG0027 affected81 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 affected58 at risk EG0014 affected27 at risk EG0026 affected81 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected58 at risk EG0013 affected27 at risk EG0023 affected81 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0014 affected27 at risk EG0025 affected81 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0011 affected27 at risk EG0021 affected81 at risk EG003
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0010 affected27 at risk EG0023 affected81 at risk EG003
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0010 affected27 at risk EG0026 affected81 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 affected58 at risk EG0012 affected27 at risk EG0021 affected81 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0011 affected27 at risk EG0023 affected81 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0013 affected27 at risk EG0027 affected81 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 affected58 at risk EG0012 affected27 at risk EG0029 affected81 at risk EG003
Lung infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected58 at risk EG0012 affected27 at risk EG0023 affected81 at risk EG003
Pneumonia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0010 affected27 at risk EG0024 affected81 at risk EG003
Oral infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected58 at risk EG0012 affected27 at risk EG0020 affected81 at risk EG003

ID	Term
D019337	Hematologic Neoplasms
D009101	Multiple Myeloma
D008228	Lymphoma, Non-Hodgkin
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D008258	Waldenstrom Macroglobulinemia
D016411	Lymphoma, T-Cell, Peripheral
D016410	Lymphoma, T-Cell, Cutaneous
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D008223	Lymphoma
D008206	Lymphatic Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D016399	Lymphoma, T-Cell
D007951	Leukemia, Myeloid
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases

ID	Title	Description
BG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
BG001	Non-Hodgkin Lymphoma (NHL) Excluding DLBCL	Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
BG002	Multiple Myeloma (MM)	Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
BG003	Acute Myeloid Leukemia (AML)	Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
BG004	Other Hematological Malignancies (ALL, CML and CLL)	Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
BG005	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Diffuse Large B-cell Lymphoma (DLBCL)	Participants with DLBCL received Selinexor in different Schedules; Schedule 1: <= 12 milligram per square meter (mg/m^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: >=40 mg/m^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.	33	58	58	58
EG001	Non-Hodgkin Lymphoma (NHL) Excluding DLBCL	Participants with NHL received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: > 12 mg/m^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly [1 Day between doses] during weeks 1 and 2; Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.	7	27	27	27
EG002	Multiple Myeloma (MM)	Participants with MM received Selinexor in different Schedules; Schedule 1: <= 12 mg/m^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m^2 total) in the 1-week run-in period; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: >= 35 mg/m^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.	52	81	80	81
EG003	Acute Myeloid Leukemia (AML)	Participants with AML received Selinexor in different Schedules; Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly (1 day between doses); Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: >=40 mg/m^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: >= 55 mg/m^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.	73	95	94	95
EG004	Other Hematological Malignancies (ALL, CML and CLL)	Participants with other hematological malignancies (Acute lymphoblastic leukemia [ALL], Chronic myelogenous leukemia [CML] and chronic lymphocytic leukemia [CLL]) received Schedule 2: > 12 mg/m^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: >=30 mg/m^2 PO twice weekly [1 day between doses]; Schedule 4: >=23 mg/m^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: >=30 mg/m^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: >=45 mg/m^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: >=45 mg/m^2 PO twice weekly in combination with 375 mg/m^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.	13	24	24	24