Selinexor (KPT-330) in Older Patients With Relapsed AML (SOPRA)

• ClinicalTrials.gov Identifier: NCT02088541
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Results First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Sponsor: Karyopharm Therapeutics Inc
• Information provided by (Responsible Party): Karyopharm Therapeutics Inc

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Myeloid Leukemia (AML)
• Interventions: Drug: Selinexor; Drug: Hydroxyurea; Drug: Ara-C
• Enrollment: 317

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)	Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2)	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 1 (PV <5)	Physician's Choice 2 (PV >=5)
Arm/Group Description	Participants under protocol versions (PV) less than (<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (milligrams per square meter) (60 to 120 mg based on body surface area [BSA]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV greater than or equal to (>=) 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.	Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Period Title: Overall Study
Started	71	27	117	44	58
Safety Population	71	27	115	39	45
Intent-to-treat (ITT) Population	0	0	118 [1]	0	57
Completed	0	0	0	0	0
Not Completed	71	27	117	44	58
Reason Not Completed
Adverse Event	3	0	3	3	0
Death	51	21	85	28	38
Lost to Follow-up	2	0	1	0	0
Physician Decision	2	1	2	0	2
Disease progression	7	1	2	3	1
Study terminated by sponsor	1	1	12	2	6
Withdrawal by Subject	3	2	9	7	10
Other	2	1	3	1	1
[1] 1 randomized to Selinexor 60mg (PV>=5) but treated with physician choice 2, counted under this arm.

Baseline Characteristics

Arm/Group Title		Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)	Selinexor 60 mg (PV<5) (Equivalent to 35 mg/m^2)	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 1 (PV <5)	Physician's Choice 2 (PV >=5)	Total
Arm/Group Description		Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV < 5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.	Participants under PV>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.	Total of all reporting groups
Overall Number of Baseline Participants		71	27	115	39	45	297
Baseline Analysis Population Description		Safety Population included all participants who received any amount of study treatment and was the primary population for the analysis of safety outcome measure.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	71 participants	27 participants	115 participants	39 participants	45 participants	297 participants
		72.4 (6.49)	73.2 (4.64)	73.6 (5.99)	72.6 (5.24)	74.2 (5.92)	73.2 (5.90)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants	27 participants	115 participants	39 participants	45 participants	297 participants
	Female	26 36.6%	11 40.7%	46 40.0%	17 43.6%	15 33.3%	115 38.7%
	Male	45 63.4%	16 59.3%	69 60.0%	22 56.4%	30 66.7%	182 61.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	71 participants	27 participants	115 participants	39 participants	45 participants	297 participants
	Hispanic or Latino	4 5.6%	3 11.1%	9 7.8%	4 10.3%	6 13.3%	26 8.8%
	Not Hispanic or Latino	65 91.5%	23 85.2%	93 80.9%	34 87.2%	31 68.9%	246 82.8%
	Unknown or Not Reported	2 2.8%	1 3.7%	13 11.3%	1 2.6%	8 17.8%	25 8.4%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Count of Participants	Number Analyzed	71 participants	27 participants	115 participants	39 participants	45 participants	297 participants
White		67	22	95	39	37	260
Black or African American		3	1	3	0	0	7
Asian		0	2	0	0	0	2
Other		0	1	15	0	6	22
Unknown		1	1	2	0	2	6

Outcome Measures

1. Primary Outcome

Title	Overall Survival
Description	Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Median (95% Confidence Interval); Unit of Measure: Days
	94.0; (78.0 to 158.0)	170.0; (111.0 to 220.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4221
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.75
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0)
Description	Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Time Frame	From randomization (Day 1) up to 3 months

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV >=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	53.49; (43.54 to 62.44)	70.73; (55.60 to 81.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9464
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR)
Description	CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of < 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) > 1000 cells/microliter (microL) and platelet count > 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	5.1; (1.9 to 10.7)	0; (0.0 to 6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0986
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

4. Secondary Outcome

Title	Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR)
Description	DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of < 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population:all participants who randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. This outcome measure(OM) was only defined for CR participants. For Physician Choice 2,there was zero CR participants."Overall Number of Participants Analyzed (N)": Number of participants evaluable for this OM.

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5, received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	6	0
Median (95% Confidence Interval); Unit of Measure: Days
	121.0 [1]; (49.0 to NA)

[1]

Upper limits of 95% confidence Interval (CI) was not estimable due to less number of participants and events.

5. Secondary Outcome

Title	Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri)
Description	mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	11.9; (6.6 to 19.1)	3.5; (0.4 to 12.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2), Physician's Choice 2 (PV >=5)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0844
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

6. Secondary Outcome

Title	Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp)
Description	DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: < 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC > 1000 cells/microL and platelet count > 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), Cri (< 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV >=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5, received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	14	2
Median (95% Confidence Interval); Unit of Measure: Days
	175.0; (61.0 to 288.0)	106.0 [1]; (NA to NA)

[1]

Upper and lower limits of 95% CI was not estimable due to the small number of participants and events.

7. Secondary Outcome

Title	Percentage of Participants With Overall Response Rate (ORR)
Description	Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. CRp; All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	13.6; (8.0 to 21.1)	8.8; (2.9 to 19.3)

8. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: <5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL, platelet count > 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count > =1.0 x10^9/L, platelet count >= 100 x10^9/L, >= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L), CRi; < 5% bone marrow blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS: morphologic bone marrow blast clearance to < 5% in marrow sample, <= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required.
Time Frame	Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks)

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. Here, "N" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	16	5
Median (95% Confidence Interval); Unit of Measure: Days
	204.0; (117.0 to 334.0)	148.0 [1]; (85.0 to NA)

[1]

Upper limit of 95% CI was not estimated due to less number of participants and events.

9. Secondary Outcome

Title	Percentage of Participants With Disease Control Rate (DCR)
Description	DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for <=4 weeks.CR:<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC >1000 cells/microL and platelet count >100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count >=1.0 x10^9/L, Platelet count >= 100*10^9/L, >=50% reduction in BM blast to 6% to 25%, or blasts <=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (<1*10^9/L) or thrombocytopenia(<100 x10^9/L),CRi;< 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS:morphologic BM blast clearance to <5% in a marrow sample in which <=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of >4 weeks.
Time Frame	Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria

Outcome Measure Data

Analysis Population Description

ITT Population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. One participant was randomized to receive selinexor 60 mg (PV>=5) but was treated with physician's choice 2. Hence, this participant was counted under selinexor 60 mg (PV>=5).

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	50.8; (41.5 to 60.2)	40.4; (27.6 to 54.2)

10. Secondary Outcome

Title	Duration of Disease Control Rate
Description	Duration of DCR calculated for all participants with DCR. CR: < 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC >1000 cells/microL and platelet count > 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count >=1.0 x 10^9/L, Platelet count >= 100 x 10^9/L, >= 50 % reduction in BM blast to 6% to 25%, or blasts <= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L), CRi; < 5% BM blasts with residual neutropenia [ANC < 1000 cells/microL] or thrombocytopenia [platelets < 100,000/microL]. MLFS; morphologic BM blast clearance to < 5% in a marrow sample in which <=200 cells enumerated/cellularity is >= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of > 4 weeks.
Time Frame	Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria

Outcome Measure Data

Analysis Population Description

ITT population included all participants who were randomized to study treatment under PV>=5.0, regardless of whether or not they received study treatment. Here," N" signifies number of participants evaluable for this measure.

Arm/Group Title	Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:	Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed	60	23
Median (95% Confidence Interval); Unit of Measure: Days
	187.0; (125.0 to 261.0)	233.0; (155.0 to 263.0)

11. Secondary Outcome

Title	Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu]
Description	QoL was assessed by the FACT-Leu. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific sub-scale (17 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI; total of 31 items) was the primary measurement of interest, comprising the Physical and Functional sub-scales plus the leukemia - specific sub-scale. Each item was rated on a 5-point Likert scale. Range from 0 = (Not at all) to 4 = (Very much); therefore, the TOI had a score ranging from 0 to 124. Higher scores indicated improvement in well being. The QoL assessment was performed at baseline (prior to first dose of study treatment), Day 1 of each cycle on or after the second, and at the final visit.
Time Frame	Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)

Outcome Measure Data

Analysis Population Description

Per-Protocol (PP) population: all participants randomized to study treatment under PV>=5.0 who received any amount of study treatment and had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n=participants evaluable for this outcome measure at specified categories.

Arm/Group Title		Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:		Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed		71	34
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	Number Analyzed	65 participants	29 participants
		70.5 (15.20)	75.4 (14.74)
C2D1	Number Analyzed	59 participants	25 participants
		0.5 (16.50)	-1.9 (15.18)
C3D1	Number Analyzed	39 participants	16 participants
		-1.9 (16.88)	-5.4 (22.25)
C4D1	Number Analyzed	26 participants	7 participants
		-1.2 (15.70)	-7.4 (25.41)
C5D1	Number Analyzed	20 participants	7 participants
		-2.4 (16.84)	1.9 (8.40)
C6D1	Number Analyzed	19 participants	6 participants
		-3.4 (15.66)	-4.7 (13.20)
C7D1	Number Analyzed	15 participants	5 participants
		-5.0 (17.21)	-11.8 (27.43)
C8D1	Number Analyzed	15 participants	5 participants
		-3.9 (15.78)	-10.6 (7.83)
C9D1	Number Analyzed	11 participants	4 participants
		-2.7 (7.47)	-8.0 (8.49)
C10D1	Number Analyzed	9 participants	3 participants
		2.4 (13.19)	-10.7 (12.70)
C11D1	Number Analyzed	7 participants	2 participants
		-0.1 (8.65)	-10.0 (9.90)
C12D1	Number Analyzed	6 participants	2 participants
		-3.7 (11.69)	-7.0 (16.97)
C13D1	Number Analyzed	4 participants	1 participants
		-3.3 (6.40)	-9.0 [1] (NA)
C14D1	Number Analyzed	3 participants	1 participants
		-4.0 (3.46)	-15.0
C15D1	Number Analyzed	2 participants	1 participants
		1.5 (3.54)	-10.0 [1] (NA)
C16D1	Number Analyzed	0 participants	1 participants
			-15.0 [1] (NA)
C17D1	Number Analyzed	1 participants	1 participants
		-15.0 [1] (NA)	-7.0 [1] (NA)
C18D1	Number Analyzed	1 participants	0 participants
		-1.0 [1] (NA)
C19D1	Number Analyzed	1 participants	0 participants
		-12.0 [1] (NA)
C20D1	Number Analyzed	1 participants	0 participants
		-14.0 [1] (NA)
Final visit	Number Analyzed	25 participants	12 participants
		2.5 (17.71)	-1.7 (20.46)

[1]

Standard Deviation was not estimated due to less number of participants.

12. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS)
Description	EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
Time Frame	Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit)

Outcome Measure Data

Analysis Population Description

PP Population included all participants randomized to study treatment under PV >=5.0 who received any amount of study treatment and who had no major protocol violations that compromised assessment of efficacy. Here, N= number of participants evaluable for this measure and n =Participants evaluable for this outcome measure at specified categories

Arm/Group Title		Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)	Physician's Choice 2 (PV >=5)
Arm/Group Description:		Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).	Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
Overall Number of Participants Analyzed		71	34
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	Number Analyzed	59 participants	30 participants
		67.9 (19.51)	63.5 (21.10)
C2D1	Number Analyzed	51 participants	25 participants
		-7.5 (23.45)	0.8 (15.82)
C3D1	Number Analyzed	35 participants	17 participants
		-13.3 (25.04)	-5.2 (23.54)
C4D1	Number Analyzed	23 participants	9 participants
		-6.1 (20.80)	-5.0 (11.46)
C5D1	Number Analyzed	18 participants	10 participants
		-0.9 (20.83)	-2.0 (15.31)
C6D1	Number Analyzed	17 participants	7 participants
		-11.2 (25.90)	-1.4 (24.10)
C7D1	Number Analyzed	14 participants	5 participants
		-3.7 (23.91)	4.0 (10.84)
C8D1	Number Analyzed	13 participants	5 participants
		0.1 (16.77)	5.0 (9.35)
C9D1	Number Analyzed	9 participants	4 participants
		4.6 (13.25)	5.0 (10.80)
C10D1	Number Analyzed	7 participants	4 participants
		0.7 (18.58)	6.3 (15.48)
C11D1	Number Analyzed	6 participants	2 participants
		0.8 (18.55)	-5.0 (21.21)
C12D1	Number Analyzed	6 participants	2 participants
		3.3 (16.63)	-5.0 (28.28)
C13D1	Number Analyzed	3 participants	1 participants
		6.7 (20.21)	10.0 [1] (NA)
C14D1	Number Analyzed	3 participants	1 participants
		6.7 (25.66)	15.0 [1] (NA)
C15D1	Number Analyzed	2 participants	1 participants
		3.5 (30.41)	-10.0 [1] (NA)
C16D1	Number Analyzed	0 participants	1 participants
			20.0 [1] (NA)
C17D1	Number Analyzed	1 participants	1 participants
		25.0 [1] (NA)	-5.0 [1] (NA)
C18D1	Number Analyzed	1 participants	0 participants
		25.0 [1] (NA)
C19D1	Number Analyzed	1 participants	0 participants
		30.0 [1] (NA)
C20D1	Number Analyzed	1 participants	0 participants
		35.0 [1] (NA)

[1]

Standard Deviation was not estimated due to less number of participants.

Adverse Events

Time Frame	From start of study drug administration to 30 days after last dose of study drug (approximately 48 months)
Adverse Event Reporting Description	Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Arm/Group Title	Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)		Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)		Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)		Physician's Choice 1 (PV <5)		Physician's Choice 2 (PV >=5)
Arm/Group Description	Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a dose of approximately 55 mg/m^2 (60 to 120 mg based on BSA) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).		Participants under PV <5.0 (those who had one prior line of AML therapy), received oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).		Participants under PV >=5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m^2) twice weekly, on Day 1 and 3 of each week of 4- week cycle (28 days per cycle).		Participants under PV < 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.		Participants under PV >= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.
All-Cause Mortality
	Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)		Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)		Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)		Physician's Choice 1 (PV <5)		Physician's Choice 2 (PV >=5)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	24/71 (33.80%)		3/27 (11.11%)		28/115 (24.35%)		7/39 (17.95%)		9/45 (20.00%)
Serious Adverse Events
	Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)		Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)		Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)		Physician's Choice 1 (PV <5)		Physician's Choice 2 (PV >=5)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/71 (81.69%)		15/27 (55.56%)		89/115 (77.39%)		25/39 (64.10%)		30/45 (66.67%)
Blood and lymphatic system disorders
Anaemia * 1	2/71 (2.82%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		3/45 (6.67%)
Febrile Neutropenia * 1	16/71 (22.54%)		4/27 (14.81%)		20/115 (17.39%)		8/39 (20.51%)		16/45 (35.56%)
Leukostasis Syndrome * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Neutropenia * 1	1/71 (1.41%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Splenic Infarction * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Thrombocytopenia * 1	1/71 (1.41%)		1/27 (3.70%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cardiac disorders
Acute Coronary Syndrome * 1	0/71 (0.00%)		1/27 (3.70%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Atrial Fibrillation * 1	2/71 (2.82%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Bradycardia * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cardiac Failure * 1	1/71 (1.41%)		0/27 (0.00%)		3/115 (2.61%)		0/39 (0.00%)		0/45 (0.00%)
Cardiac Failure Congestive * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cardio-Respiratory Arrest * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Sinus Bradycardia * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Tachyarrhythmia * 1	0/71 (0.00%)		1/27 (3.70%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Ventricular Fibrillation * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Ear and labyrinth disorders
Vertigo * 1	0/71 (0.00%)		1/27 (3.70%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Eye disorders
Cataract * 1	0/71 (0.00%)		0/27 (0.00%)		3/115 (2.61%)		0/39 (0.00%)		0/45 (0.00%)
Gastrointestinal disorders
Abdominal Pain Upper * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Constipation * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Diarrhoea * 1	3/71 (4.23%)		1/27 (3.70%)		6/115 (5.22%)		0/39 (0.00%)		0/45 (0.00%)
Diverticular Perforation * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Gastrointestinal Haemorrhage * 1	0/71 (0.00%)		1/27 (3.70%)		1/115 (0.87%)		1/39 (2.56%)		0/45 (0.00%)
Large Intestinal Haemorrhage * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Mouth Ulceration * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Nausea * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Tooth Loss * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Vomiting * 1	4/71 (5.63%)		0/27 (0.00%)		3/115 (2.61%)		0/39 (0.00%)		0/45 (0.00%)
General disorders
Asthenia * 1	3/71 (4.23%)		0/27 (0.00%)		2/115 (1.74%)		2/39 (5.13%)		0/45 (0.00%)
Condition Aggravated * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
General Physical Health Deterioration * 1	1/71 (1.41%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Malaise * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Multiple Organ Dysfunction Syndrome * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Pain * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Pyrexia * 1	4/71 (5.63%)		1/27 (3.70%)		7/115 (6.09%)		2/39 (5.13%)		1/45 (2.22%)
Fatigue * 1	1/71 (1.41%)		0/27 (0.00%)		8/115 (6.96%)		0/39 (0.00%)		0/45 (0.00%)
Hepatobiliary disorders
Cholecystitis Acute * 1	0/71 (0.00%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Hyperbilirubinaemia * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Infections and infestations
Arthritis Bacterial * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Aspergillus Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Biliary Sepsis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Biliary Tract Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cellulitis * 1	2/71 (2.82%)		0/27 (0.00%)		1/115 (0.87%)		1/39 (2.56%)		1/45 (2.22%)
Clostridium Difficile Infection * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Device Related Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		1/39 (2.56%)		1/45 (2.22%)
Diverticulitis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Escherichia Sepsis * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		1/45 (2.22%)
Fungal Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		2/45 (4.44%)
Klebsiella Sepsis * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Laryngitis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Lower Respiratory Tract Infection * 1	1/71 (1.41%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Lung Infection * 1	3/71 (4.23%)		1/27 (3.70%)		1/115 (0.87%)		3/39 (7.69%)		0/45 (0.00%)
Necrotising Fasciitis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Neutropenic Sepsis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Penile Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Perirectal Abscess * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Pneumocystis Jirovecii Pneumonia * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Pneumonia * 1	10/71 (14.08%)		4/27 (14.81%)		10/115 (8.70%)		4/39 (10.26%)		3/45 (6.67%)
Pneumonia Fungal * 1	2/71 (2.82%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Sepsis * 1	8/71 (11.27%)		1/27 (3.70%)		3/115 (2.61%)		3/39 (7.69%)		1/45 (2.22%)
Septic Shock * 1	1/71 (1.41%)		0/27 (0.00%)		3/115 (2.61%)		1/39 (2.56%)		0/45 (0.00%)
Sialoadenitis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Sinusitis * 1	2/71 (2.82%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Skin Infection * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Soft Tissue Infection * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Tonsillitis * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Upper Respiratory Tract Infection * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Urinary Tract Infection * 1	0/71 (0.00%)		0/27 (0.00%)		3/115 (2.61%)		1/39 (2.56%)		0/45 (0.00%)
Urosepsis * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Vaginal Abscess * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Vulval Cellulitis * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Injury, poisoning and procedural complications
Fall * 1	0/71 (0.00%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		1/45 (2.22%)
Femur Fracture * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Subarachnoid Haemorrhage * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Subdural Haematoma * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		1/39 (2.56%)		0/45 (0.00%)
Subdural Haemorrhage * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Investigations
Blood Alkaline Phosphatase Increased * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
C-Reactive Protein Increased * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Electrocardiogram Change * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Enterococcus Test Positive * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Troponin T Increased * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Vitamin B12 Decreased * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Weight Decreased * 1	1/71 (1.41%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Metabolism and nutrition disorders
Decreased Appetite * 1	1/71 (1.41%)		0/27 (0.00%)		6/115 (5.22%)		0/39 (0.00%)		0/45 (0.00%)
Dehydration * 1	5/71 (7.04%)		0/27 (0.00%)		2/115 (1.74%)		1/39 (2.56%)		0/45 (0.00%)
Failure To Thrive * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Fluid Overload * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		1/39 (2.56%)		0/45 (0.00%)
Hypercreatininaemia * 1	0/71 (0.00%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Hyperglycaemia * 1	5/71 (7.04%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Hyperkalaemia * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Hyponatraemia * 1	3/71 (4.23%)		1/27 (3.70%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Hypophagia * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Musculoskeletal and connective tissue disorders
Bone Pain * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Muscular Weakness * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cerebellar Tumour * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Squamous Cell Carcinoma * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Nervous system disorders
Ataxia * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cerebral Haemorrhage * 1	1/71 (1.41%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		1/45 (2.22%)
Cerebral Infarction * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Cerebrovascular Accident * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Dizziness * 1	1/71 (1.41%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Embolic Stroke * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Encephalopathy * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Haemorrhage Intracranial * 1	2/71 (2.82%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Haemorrhagic Cerebral Infarction * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Headache * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Ischaemic Stroke * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Loss Of Consciousness * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Nervous System Disorders * 1	8/71 (11.27%)		1/27 (3.70%)		15/115 (13.04%)		0/39 (0.00%)		1/45 (2.22%)
Presyncope * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Syncope * 1	2/71 (2.82%)		1/27 (3.70%)		3/115 (2.61%)		0/39 (0.00%)		0/45 (0.00%)
Psychiatric disorders
Confusional State * 1	4/71 (5.63%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Hallucination * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Mental Status Changes * 1	1/71 (1.41%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Organic Brain Syndrome * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Renal and urinary disorders
Acute Kidney Injury * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Oliguria * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Renal Failure * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Reproductive system and breast disorders
Vaginal Haemorrhage * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Cough * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Dyspnoea * 1	2/71 (2.82%)		1/27 (3.70%)		3/115 (2.61%)		1/39 (2.56%)		0/45 (0.00%)
Epistaxis * 1	2/71 (2.82%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		2/45 (4.44%)
Haemoptysis * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		1/45 (2.22%)
Pleural Effusion * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		1/45 (2.22%)
Pneumonia Aspiration * 1	2/71 (2.82%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Pulmonary Embolism * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Pulmonary Mass * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Respiratory Failure * 1	2/71 (2.82%)		0/27 (0.00%)		2/115 (1.74%)		0/39 (0.00%)		0/45 (0.00%)
Social circumstances
Social Stay Hospitalisation * 1	0/71 (0.00%)		1/27 (3.70%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Vascular disorders
Aortic Aneurysm * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Haematoma * 1	1/71 (1.41%)		0/27 (0.00%)		0/115 (0.00%)		0/39 (0.00%)		0/45 (0.00%)
Hypotension * 1	1/71 (1.41%)		0/27 (0.00%)		4/115 (3.48%)		0/39 (0.00%)		0/45 (0.00%)
Peripheral Ischaemia * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
Thrombophlebitis * 1	0/71 (0.00%)		0/27 (0.00%)		0/115 (0.00%)		1/39 (2.56%)		0/45 (0.00%)
Venous Thrombosis * 1	0/71 (0.00%)		0/27 (0.00%)		1/115 (0.87%)		0/39 (0.00%)		0/45 (0.00%)
1 Term from vocabulary, MedDRA 20.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Selinexor Approximately 55 mg/m^2 (60 to 120 mg Based on BSA)		Selinexor 60mg (PV<5) (Equivalent to 35 mg/m^2)		Selinexor 60mg (PV >=5) (Equivalent to 35 mg/m^2)		Physician's Choice 1 (PV <5)		Physician's Choice 2 (PV >=5)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/71 (100.00%)		27/27 (100.00%)		113/115 (98.26%)		37/39 (94.87%)		40/45 (88.89%)
Blood and lymphatic system disorders
Thrombocytopenia * 1	29/71 (40.85%)	29	7/27 (25.93%)	7	38/115 (33.04%)	38	18/39 (46.15%)	18	11/45 (24.44%)	11
Anaemia * 1	20/71 (28.17%)	20	7/27 (25.93%)	7	29/115 (25.22%)	29	17/39 (43.59%)	17	10/45 (22.22%)	10
Neutropenia * 1	6/71 (8.45%)	6	5/27 (18.52%)	5	17/115 (14.78%)	17	10/39 (25.64%)	10	9/45 (20.00%)	9
Leukopenia * 1	2/71 (2.82%)	2	3/27 (11.11%)	3	10/115 (8.70%)	10	5/39 (12.82%)	5	4/45 (8.89%)	4
Febrile Neutropenia * 1	9/71 (12.68%)	9	2/27 (7.41%)	2	7/115 (6.09%)	7	3/39 (7.69%)	3	2/45 (4.44%)	2
Leukocytosis * 1	6/71 (8.45%)	6	2/27 (7.41%)	2	6/115 (5.22%)	6	4/39 (10.26%)	4	0/45 (0.00%)	0
Lymphopenia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	2/39 (5.13%)	2	1/45 (2.22%)	1
Pancytopenia * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	2/39 (5.13%)	2	0/45 (0.00%)	0
Coagulopathy * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	2/115 (1.74%)	2	1/39 (2.56%)	1	0/45 (0.00%)	0
Lymphadenopathy * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	1/45 (2.22%)	1
Increased Tendency To Bruise * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Polycythaemia * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Splenomegaly * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Thrombocytosis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Cardiac disorders
Tachycardia * 1	5/71 (7.04%)	5	1/27 (3.70%)	1	4/115 (3.48%)	4	0/39 (0.00%)	0	2/45 (4.44%)	2
Sinus Tachycardia * 1	4/71 (5.63%)	4	1/27 (3.70%)	1	2/115 (1.74%)	2	1/39 (2.56%)	1	0/45 (0.00%)	0
Atrial Fibrillation * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	2/39 (5.13%)	2	1/45 (2.22%)	1
Bradycardia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Acute Left Ventricular Failure * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Angina Pectoris * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Arrhythmia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Bundle Branch Block Right * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Cardiac Failure * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Cardiac Flutter * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Extrasystoles * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Palpitations * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Sinus Bradycardia * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Supraventricular Tachycardia * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Tachycardia Paroxysmal * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Ear and labyrinth disorders
Deafness * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	1/45 (2.22%)	1
Ear Discomfort * 1	0/71 (0.00%)	0	2/27 (7.41%)	2	2/115 (1.74%)	2	0/39 (0.00%)	0	1/45 (2.22%)	1
Vertigo * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	3/115 (2.61%)	3	0/39 (0.00%)	0	1/45 (2.22%)	1
Ear Pain * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Tinnitus * 1	3/71 (4.23%)	3	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Ear Congestion * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Eustachian Tube Dysfunction * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Excessive Cerumen Production * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Hypoacusis * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Endocrine disorders
Hypothyroidism * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	4/115 (3.48%)	4	1/39 (2.56%)	1	0/45 (0.00%)	0
Cushingoid * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Hyperthyroidism * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Eye disorders
Vision Blurred * 1	8/71 (11.27%)	8	1/27 (3.70%)	1	9/115 (7.83%)	9	1/39 (2.56%)	1	0/45 (0.00%)	0
Visual Impairment * 1	4/71 (5.63%)	4	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	1/45 (2.22%)	1
Cataract * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	3/115 (2.61%)	3	0/39 (0.00%)	0	0/45 (0.00%)	0
Dry Eye * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Visual Acuity Reduced * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	1/45 (2.22%)	1
Conjunctival Haemorrhage * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	2/39 (5.13%)	2	0/45 (0.00%)	0
Eye Pain * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Lacrimation Increased * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Eye Haemorrhage * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Eyelid Oedema * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Ocular Hyperaemia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Periorbital Oedema * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Photopsia * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Retinal Haemorrhage * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Diplopia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Eye Inflammation * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Eye Swelling * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Eyelid Ptosis * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Vitreous Floaters * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Vitreous Haemorrhage * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Gastrointestinal disorders
Nausea * 1	41/71 (57.75%)	41	16/27 (59.26%)	16	68/115 (59.13%)	68	13/39 (33.33%)	13	8/45 (17.78%)	8
Diarrhoea * 1	17/71 (23.94%)	17	13/27 (48.15%)	13	41/115 (35.65%)	41	8/39 (20.51%)	8	6/45 (13.33%)	6
Constipation * 1	20/71 (28.17%)	20	8/27 (29.63%)	8	25/115 (21.74%)	25	16/39 (41.03%)	16	15/45 (33.33%)	15
Vomiting * 1	19/71 (26.76%)	19	10/27 (37.04%)	10	30/115 (26.09%)	30	7/39 (17.95%)	7	6/45 (13.33%)	6
Stomatitis * 1	8/71 (11.27%)	8	0/27 (0.00%)	0	8/115 (6.96%)	8	3/39 (7.69%)	3	3/45 (6.67%)	3
Abdominal Pain * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	12/115 (10.43%)	12	2/39 (5.13%)	2	6/45 (13.33%)	6
Abdominal Pain Upper * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	6/115 (5.22%)	6	1/39 (2.56%)	1	1/45 (2.22%)	1
Dyspepsia * 1	3/71 (4.23%)	3	2/27 (7.41%)	2	3/115 (2.61%)	3	1/39 (2.56%)	1	1/45 (2.22%)	1
Gingival Bleeding * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	7/115 (6.09%)	7	1/39 (2.56%)	1	2/45 (4.44%)	2
Haemorrhoids * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	3/115 (2.61%)	3	2/39 (5.13%)	2	3/45 (6.67%)	3
Aphthous Ulcer * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	1/115 (0.87%)	1	2/39 (5.13%)	2	2/45 (4.44%)	2
Mouth Haemorrhage * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	4/115 (3.48%)	4	1/39 (2.56%)	1	0/45 (0.00%)	0
Abdominal Discomfort * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	1/115 (0.87%)	1	2/39 (5.13%)	2	2/45 (4.44%)	2
Gingival Pain * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	3/115 (2.61%)	3	2/39 (5.13%)	2	0/45 (0.00%)	0
Odynophagia * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	0/115 (0.00%)	0	2/39 (5.13%)	2	2/45 (4.44%)	2
Toothache * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	3/115 (2.61%)	3	0/39 (0.00%)	0	1/45 (2.22%)	1
Dry Mouth * 1	2/71 (2.82%)	2	1/27 (3.70%)	1	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Gastrooesophageal Reflux Disease * 1	3/71 (4.23%)	3	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Dysphagia * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Flatulence * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	3/115 (2.61%)	3	1/39 (2.56%)	1	0/45 (0.00%)	0
Melaena * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	2/45 (4.44%)	2
Oral Pain * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	2/39 (5.13%)	2	0/45 (0.00%)	0
Abdominal Pain Lower * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Anal Fissure * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Angina Bullosa Haemorrhagica * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	2/39 (5.13%)	2	0/45 (0.00%)	0
Enterocolitis * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Eructation * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Gastritis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Gastrointestinal Haemorrhage * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Mouth Ulceration * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Oral Disorder * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Oral Mucosa Haematoma * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Oral Mucosal Blistering * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Abdominal Tenderness * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Anal Incontinence * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Breath Odour * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Diverticulum * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Faeces Soft * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Gastrointestinal Pain * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Gingival Hypertrophy * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Glossitis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Ileus * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Inguinal Hernia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Lip Blister * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Lip Dry * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Lip Oedema * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Lip Pain * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Lip Swelling * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Lip Ulceration * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Mouth Swelling * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Oesophagitis * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Oral Contusion * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Oral Dysaesthesia * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Palatal Disorder * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Perianal Erythema * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Proctalgia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Rectal Fissure * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Rectal Haemorrhage * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Retching * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Salivary Hypersecretion * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Tongue Haematoma * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Tongue Ulceration * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Tooth Loss * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Trichoglossia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
General disorders
Fatigue * 1	33/71 (46.48%)	33	13/27 (48.15%)	13	50/115 (43.48%)	50	15/39 (38.46%)	15	13/45 (28.89%)	13
Pyrexia * 1	8/71 (11.27%)	8	5/27 (18.52%)	5	28/115 (24.35%)	28	13/39 (33.33%)	13	13/45 (28.89%)	13
Oedema Peripheral * 1	17/71 (23.94%)	17	5/27 (18.52%)	5	21/115 (18.26%)	21	10/39 (25.64%)	10	5/45 (11.11%)	5
Asthenia * 1	17/71 (23.94%)	17	6/27 (22.22%)	6	22/115 (19.13%)	22	5/39 (12.82%)	5	5/45 (11.11%)	5
Malaise * 1	2/71 (2.82%)	2	1/27 (3.70%)	1	8/115 (6.96%)	8	3/39 (7.69%)	3	1/45 (2.22%)	1
Oedema * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	5/115 (4.35%)	5	4/39 (10.26%)	4	2/45 (4.44%)	2
Chills * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	5/115 (4.35%)	5	3/39 (7.69%)	3	1/45 (2.22%)	1
Mucosal Inflammation * 1	3/71 (4.23%)	3	0/27 (0.00%)	0	1/115 (0.87%)	1	4/39 (10.26%)	4	3/45 (6.67%)	3
Pain * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	7/115 (6.09%)	7	1/39 (2.56%)	1	1/45 (2.22%)	1
Gait Disturbance * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
General Physical Health Deterioration * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Injection Site Bruising * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	1/45 (2.22%)	1
Non-Cardiac Chest Pain * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Ulcer * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Catheter Site Haemorrhage * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Face Oedema * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Generalised Oedema * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Secretion Discharge * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Catheter Site Haematoma * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Chest Pain * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Drug Intolerance * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Extravasation * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Feeling Cold * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Granuloma * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Hernia * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Impaired Healing * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Infusion Site Haemorrhage * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Injection Site Discolouration * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Injection Site Pain * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Mucosal Dryness * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Nodule * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Peripheral Swelling * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Swelling * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Decreased Appetite * 1	41/71 (57.75%)	41	12/27 (44.44%)	12	61/115 (53.04%)	61	9/39 (23.08%)	9	7/45 (15.56%)	7
Hepatobiliary disorders
Hyperbilirubinaemia * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	5/115 (4.35%)	5	1/39 (2.56%)	1	1/45 (2.22%)	1
Cholelithiasis * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Hepatomegaly * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Jaundice * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Ocular Icterus * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Immune system disorders
Hypersensitivity * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Infections and infestations
Urinary Tract Infection * 1	6/71 (8.45%)	6	2/27 (7.41%)	2	9/115 (7.83%)	9	5/39 (12.82%)	5	2/45 (4.44%)	2
Oral Herpes * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	3/115 (2.61%)	3	4/39 (10.26%)	4	4/45 (8.89%)	4
Nasopharyngitis * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	5/115 (4.35%)	5	1/39 (2.56%)	1	3/45 (6.67%)	3
Oral Candidiasis * 1	4/71 (5.63%)	4	0/27 (0.00%)	0	4/115 (3.48%)	4	1/39 (2.56%)	1	1/45 (2.22%)	1
Pneumonia * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	4/115 (3.48%)	4	3/39 (7.69%)	3	1/45 (2.22%)	1
Cellulitis * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	2/115 (1.74%)	2	1/39 (2.56%)	1	1/45 (2.22%)	1
Lung Infection * 1	2/71 (2.82%)	2	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Sinusitis * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	2/115 (1.74%)	2	2/39 (5.13%)	2	0/45 (0.00%)	0
Upper Respiratory Tract Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	1/39 (2.56%)	1	1/45 (2.22%)	1
Device Related Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	2/115 (1.74%)	2	1/39 (2.56%)	1	0/45 (0.00%)	0
Periodontitis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	2/45 (4.44%)	2
Pneumonia Fungal * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	3/45 (6.67%)	3
Sepsis * 1	1/71 (1.41%)	1	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Candida Infection * 1	3/71 (4.23%)	3	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Folliculitis * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Oesophageal Candidiasis * 1	0/71 (0.00%)	0	2/27 (7.41%)	2	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Skin Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	1/39 (2.56%)	1	0/45 (0.00%)	0
Staphylococcal Infection * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	2/45 (4.44%)	2
Clostridium Difficile Colitis * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Clostridium Difficile Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Conjunctivitis * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Ear Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Fungal Infection * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	2/115 (1.74%)	2	0/39 (0.00%)	0	0/45 (0.00%)	0
Herpes Dermatitis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Infection * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	1/39 (2.56%)	1	1/45 (2.22%)	1
Lip Infection * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Nasal Herpes * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	0/45 (0.00%)	0
Pharyngitis * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	0/115 (0.00%)	0	2/39 (5.13%)	2	0/45 (0.00%)	0
Pseudomonas Infection * 1	0/71 (0.00%)	0	0/27 (0.00%)	0	1/115 (0.87%)	1	0/39 (0.00%)	0	1/45 (2.22%)	1
Rash Pustular * 1	0/71 (0.00%)	0	1/27 (3.70%)	1	0/115 (0.00%)	0	1/39 (2.56%)	1	0/45 (0.00%)	0
Rhinovirus Infection * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	1/45 (2.22%)	1
Soft Tissue Infection * 1	2/71 (2.82%)	2	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Abscess Limb * 1	1/71 (1.41%)	1	0/27 (0.00%)	0	0/115 (0.00%)	0	0/39 (0.00%)	0	0/45 (0.00%)	0
Acute Sinusitis * 1