Trial Outcomes & Findings for Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies (NCT NCT02025985)

NCT ID: NCT02025985

Last Updated: 2023-01-26

Results Overview

Disease Control Rate (DCR) was defined as the point estimate of the percentage of participants who had complete response (CR), partial response (PR), or stable disease (SD) for at least 12 weeks, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants without documented disease progression were censored on the date of last radiologic assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

Baseline up to 30 days after last dose administration, assessed after 6 weeks and 12 weeks (approximately 35 months)

Results posted on

2023-01-26

Participant Flow

The study was conducted between 09-April-2014 and 29-Mar-2017.

A total of 116 participants were enrolled out of which 2 participants discontinued the study before the start of the treatment (1 participant due to death and 1 participant due to other reason). Total 114 participants started the study treatment.

Participant milestones

Participant milestones
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 milligram per meter square (mg/m\^2) of selinexor oral tablets twice weekly (BIW) (doses at least 36 hours apart) with light meal and 120 milliliters (mL) of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 once weekly (QW). This treatment continued until progression of disease (PD) or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIWmg/m^2 Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Overall Study STARTED	25	23	25	21	20
Overall Study Modified Intent-to-treat(mITT)Population	23	22	25	21	20
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	25	23	25	21	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 milligram per meter square (mg/m\^2) of selinexor oral tablets twice weekly (BIW) (doses at least 36 hours apart) with light meal and 120 milliliters (mL) of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 once weekly (QW). This treatment continued until progression of disease (PD) or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIWmg/m^2 Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Overall Study Consent withdrawn	0	0	1	0	0
Overall Study Termination of study by Sponsor	4	3	1	1	3
Overall Study Death	21	20	23	20	17

Baseline Characteristics

Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	70 Participants n=8 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	17 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	44 Participants n=8 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	21 Participants n=4 Participants	20 Participants n=21 Participants	114 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	21 Participants n=4 Participants	20 Participants n=21 Participants	114 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Race · White	25 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	21 Participants n=4 Participants	20 Participants n=21 Participants	113 Participants n=8 Participants
Race/Ethnicity, Customized Race · Other-unspecified	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after last dose administration, assessed after 6 weeks and 12 weeks (approximately 35 months)

Population: Analysis was performed on modified intent-to-treat (mITT) population that included all participants who received at least 1 dose of study drug, had measurable disease per RECIST at baseline, and had at least 1 post-baseline efficacy follow-up information.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Percentage of Participants With Disease Control Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	30.4 percentage of participants Interval 13.2 to 52.9	36.4 percentage of participants Interval 17.2 to 59.3	24.0 percentage of participants Interval 9.4 to 45.1	33.3 percentage of participants Interval 14.6 to 57.0	30.0 percentage of participants Interval 11.9 to 54.3

SECONDARY outcome

Timeframe: Baseline up to the date of progression or recurrence (approximately 35 months)

Overall Response Rate (ORR) was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Percentage of Participants With Overall Response According to RECIST v1.1	8.7 percentage of participants Interval 1.1 to 28.0	13.6 percentage of participants Interval 2.9 to 34.9	4.0 percentage of participants Interval 0.1 to 20.4	9.5 percentage of participants Interval 1.2 to 30.4	15.0 percentage of participants Interval 3.2 to 37.9

SECONDARY outcome

Timeframe: Baseline up to 30 days after last dose administration, assessed after 6 weeks and 12 weeks (approximately 35 months)

Population: Analysis was performed on GCIG evaluable population that included all participants in the ovarian cancer cohort (Cohort A) who had received at least 1 dose of study drug, had measurable disease per RECIST at baseline or baseline CA-125 assessment, and had at least 1 post-baseline efficacy follow-up information (i.e., either post-baseline scan or CA-125 assessment). Data for this outcome measure was not planned to be collected and analyzed for Cohort B and Cohort C, as pre-specified in protocol.

DCR was defined as the point estimate of the percentage of participants who had CR, PR, or SD for at least 12 weeks, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=16 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=20 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Percentage of Participants With Disease Control According to Gynecological Cancer Intergroup (GCIG) Response Criteria	16.0 percentage of participants Interval 4.5 to 36.1	23.8 percentage of participants Interval 8.2 to 47.2	20.0 percentage of participants Interval 5.7 to 43.7	—	—

SECONDARY outcome

Timeframe: Baseline up to the date of progression or recurrence (approximately 35 months)

Population: Analysis was performed on GCIG evaluable population that included all participants in the ovarian cancer cohort (Cohort A) who had received at least 1 dose of study drug, had measurable disease per RECIST at baseline or baseline CA-125 assessment, and had at least 1 post-baseline efficacy follow-up information (i.e., either post-baseline scan or CA-125 assessment). Data for this outcome measure were not planned to be collected and analyzed for Cohort B and Cohort C, as pre-specified in protocol.

ORR was defined as the point estimate of the percentage of participants who had CR or PR, assessed according to GCIG response criteria (RECIST v1.1 and CA-125).

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=21 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=20 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Percentage of Participants With Overall Response According to GCIG Response Criteria	4.0 percentage of participants Interval 0.1 to 20.4	9.5 percentage of participants Interval 1.2 to 30.4	10.0 percentage of participants Interval 1.2 to 31.7	—	—

SECONDARY outcome

Timeframe: From start of study drug administration until PD or discontinuation from the study or death, whichever occurred first (approximately 35 months)

PFS was defined as the time from date of start of study therapy to the date of tumor disease progression (i.e., radiological only) or date of death due to any cause. Participants without documented disease progression were censored at the time of last radiologic assessment. Participants without any post baseline assessments were censored at date of start of study therapy.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Progression-free Survival (PFS) According to RECIST v1.1	79.0 days Interval 45.0 to 99.0	86.5 days Interval 43.0 to 182.0	44.0 days Interval 43.0 to 141.0	85.0 days Interval 44.0 to 148.0	44.5 days Interval 43.0 to 140.0

SECONDARY outcome

Timeframe: From start of study treatment up to the date of death, assessed every 3 months (approximately 35 months)

OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or were lost to follow-up were censored at the day they were last known to be alive. Kaplan-Maier method was used for estimation.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Overall Survival (OS)	172.0 days Interval 62.0 to 372.0	226.0 days Interval 111.0 to 449.0	152.0 days Interval 83.0 to 254.0	348.0 days Interval 149.0 to 401.0	173.0 days Interval 105.0 to 353.0

SECONDARY outcome

Timeframe: 12 and 24 months

OS rate was reported as the percentage of participants who were alive at 12 and 24 months. OS was defined as time from the date of start of study therapy to the date of death due to any cause. Participants who were alive at the time of the analysis or are lost to follow-up were censored at the day they were last known to be alive. Survival rate were estimated by Kaplan-Maier method.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Percentage of Participants Who Survived at 12 and 24 Months 12 months	34.8 percentage of participants Interval 16.6 to 53.7	31.8 percentage of participants Interval 14.2 to 51.1	13.2 percentage of participants Interval 3.4 to 29.9	33.3 percentage of participants Interval 14.9 to 53.1	25.0 percentage of participants Interval 9.1 to 44.9
Percentage of Participants Who Survived at 12 and 24 Months 24 months	21.7 percentage of participants Interval 7.9 to 39.9	13.6 percentage of participants Interval 3.4 to 30.9	4.4 percentage of participants Interval 0.3 to 18.4	19.0 percentage of participants Interval 5.9 to 37.7	15.0 percentage of participants Interval 3.7 to 33.5

SECONDARY outcome

Timeframe: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)

Population: Analysis was performed on safety population that included all participants who had received any amount of study drug.

An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria, i.e., fatal, life threatening (places the participants at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. TEAE was defined as any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study medication through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 Participants with TEAE	25 Participants	23 Participants	25 Participants	21 Participants	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 Participants with TESAE	14 Participants	14 Participants	6 Participants	12 Participants	12 Participants

SECONDARY outcome

Timeframe: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)

Population: Analysis was performed on safety population that included all participants who had received any amount of study drug.

AE: any unfavorable and unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not it is considered related to medicinal product. TEAE: any AE (serious/non-serious) with onset or worsening of a pre-existing condition on or after the first administration of study drug through 30 days following last dose or any event considered drug-related by investigator through end of study. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03 Mild (Grade 1)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03 Moderate (Grade 2)	3 Participants	3 Participants	5 Participants	5 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03 Severe (Grade 3)	19 Participants	17 Participants	17 Participants	15 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03 Life threatening (Grade 4)	3 Participants	2 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE, Version 4.03 Fatal (Grade 5)	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, End of treatment (EOT) i.e., 30 days after last dose of study drug administration (up to 31 months)

Population: Analysis was performed on mITT population that included all participants who received at least 1 dose of study drug, had measurable disease per RECIST at baseline, and had at least 1 post-baseline efficacy follow-up information. Here, 'Overall number of participants analyzed' signifies participants with available data for the outcome measure and "Number analyzed' signifies number of participants with available data for specified categories.

EORTC QLQC30: Disease specific indication that rates overall QoL in cancer participants. It consists of 30 general questions from 3 domains; 1) global health status, 2) functioning scales (physical, emotional, cognitive, social and role functioning), 3) symptom scales (fatigue, nausea, vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea, financial difficulty). Out of 30 questions, 28 questions were scored using scale of 1 to 4, represented answers of 'not at all', 'a little', 'quite a bit', and 'very much'; remaining 2 questions contributed to global health status were scored on scale of 1 to 7, represented range of 'very poor' to 'excellent' that evaluated overall health and QoL. All scales and single-item measures range from 0 to 100, where higher score represented higher response level. Higher score for functional scale, global health status and symptom scale represented high level of functioning, high QoL, and high level of symptoms or problems, respectively.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=21 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Global Health Status/ QoL: Baseline	52.8 scores on a scale Standard Deviation 22.41	59.5 scores on a scale Standard Deviation 20.63	60.2 scores on a scale Standard Deviation 24.25	61.5 scores on a scale Standard Deviation 22.89	57.5 scores on a scale Standard Deviation 21.95
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Global Health Status/ QoL: EOT	-8.3 scores on a scale Standard Deviation 11.79	-11.4 scores on a scale Standard Deviation 29.88	-14.6 scores on a scale Standard Deviation 10.49	-27.4 scores on a scale Standard Deviation 31.81	-13.9 scores on a scale Standard Deviation 15.52
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Physical Functioning: Baseline	69.5 scores on a scale Standard Deviation 19.16	70.9 scores on a scale Standard Deviation 21.54	66.1 scores on a scale Standard Deviation 26.02	67.1 scores on a scale Standard Deviation 21.14	70.7 scores on a scale Standard Deviation 25.26
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Physical Functioning: EOT	-26.7 scores on a scale Standard Deviation 28.28	-16.4 scores on a scale Standard Deviation 27.55	-24.2 scores on a scale Standard Deviation 21.32	-7.6 scores on a scale Standard Deviation 16.97	-18.9 scores on a scale Standard Deviation 14.25
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Role Functioning: Baseline	54.0 scores on a scale Standard Deviation 29.77	59.5 scores on a scale Standard Deviation 31.87	55.6 scores on a scale Standard Deviation 35.49	59.5 scores on a scale Standard Deviation 28.66	63.3 scores on a scale Standard Deviation 34.45
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Role Functioning: EOT	-33.3 scores on a scale Standard Deviation 47.14	-3.0 scores on a scale Standard Deviation 49.90	-20.8 scores on a scale Standard Deviation 36.96	-9.5 scores on a scale Standard Deviation 39.51	-25.0 scores on a scale Standard Deviation 9.13
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Emotional Functioning: Baseline	62.3 scores on a scale Standard Deviation 24.81	69.8 scores on a scale Standard Deviation 24.65	71.2 scores on a scale Standard Deviation 23.81	74.2 scores on a scale Standard Deviation 19.53	66.3 scores on a scale Standard Deviation 23.33
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Emotional Functioning: EOT	-16.7 scores on a scale Standard Deviation 11.79	-0.8 scores on a scale Standard Deviation 38.27	12.5 scores on a scale Standard Deviation 14.43	-13.9 scores on a scale Standard Deviation 23.07	-2.8 scores on a scale Standard Deviation 17.21
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Cognitive Functioning: Baseline	81.0 scores on a scale Standard Deviation 22.54	86.5 scores on a scale Standard Deviation 16.35	83.3 scores on a scale Standard Deviation 25.20	83.3 scores on a scale Standard Deviation 19.00	80.8 scores on a scale Standard Deviation 23.12
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Cognitive Functioning: EOT	-33.3 scores on a scale Standard Deviation 23.57	-6.1 scores on a scale Standard Deviation 29.13	4.2 scores on a scale Standard Deviation 20.97	-16.7 scores on a scale Standard Deviation 38.49	0.0 scores on a scale Standard Deviation 0.00
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Social Functioning: Baseline	61.1 scores on a scale Standard Deviation 29.97	76.2 scores on a scale Standard Deviation 32.31	72.7 scores on a scale Standard Deviation 28.89	69.0 scores on a scale Standard Deviation 30.86	77.5 scores on a scale Standard Deviation 29.75
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Functioning Scales/ Social Functioning: EOT	-33.3 scores on a scale Standard Deviation 0.00	-6.1 scores on a scale Standard Deviation 48.46	-20.8 scores on a scale Standard Deviation 20.97	-7.1 scores on a scale Standard Deviation 18.90	-30.6 scores on a scale Standard Deviation 32.35
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Fatigue: Baseline	46.6 scores on a scale Standard Deviation 27.80	43.4 scores on a scale Standard Deviation 27.42	44.9 scores on a scale Standard Deviation 27.75	46.0 scores on a scale Standard Deviation 27.28	41.7 scores on a scale Standard Deviation 27.89
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Fatigue: EOT	33.3 scores on a scale Standard Deviation 47.14	6.1 scores on a scale Standard Deviation 41.09	1.4 scores on a scale Standard Deviation 17.20	23.8 scores on a scale Standard Deviation 30.38	16.7 scores on a scale Standard Deviation 11.65
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Nausea And Vomiting: Baseline	13.5 scores on a scale Standard Deviation 24.51	17.5 scores on a scale Standard Deviation 30.04	9.8 scores on a scale Standard Deviation 15.99	5.6 scores on a scale Standard Deviation 14.27	10.8 scores on a scale Standard Deviation 21.81
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Nausea And Vomiting: EOT	8.3 scores on a scale Standard Deviation 11.79	-0.0 scores on a scale Standard Deviation 40.82	16.7 scores on a scale Standard Deviation 19.25	9.5 scores on a scale Standard Deviation 23.29	13.9 scores on a scale Standard Deviation 16.39
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Pain: Baseline	34.9 scores on a scale Standard Deviation 27.84	37.3 scores on a scale Standard Deviation 27.34	32.6 scores on a scale Standard Deviation 27.93	31.0 scores on a scale Standard Deviation 29.48	32.5 scores on a scale Standard Deviation 26.75
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Pain: EOT	-8.3 scores on a scale Standard Deviation 11.79	-4.5 scores on a scale Standard Deviation 21.20	4.2 scores on a scale Standard Deviation 8.33	-2.4 scores on a scale Standard Deviation 17.82	2.8 scores on a scale Standard Deviation 26.70
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Dyspnoea: Baseline	23.8 scores on a scale Standard Deviation 31.87	30.2 scores on a scale Standard Deviation 36.37	19.7 scores on a scale Standard Deviation 30.27	33.3 scores on a scale Standard Deviation 38.01	21.7 scores on a scale Standard Deviation 29.17
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Dyspnoea: EOT	50.0 scores on a scale Standard Deviation 23.57	6.1 scores on a scale Standard Deviation 32.72	8.3 scores on a scale Standard Deviation 16.67	-0.0 scores on a scale Standard Deviation 47.14	16.7 scores on a scale Standard Deviation 18.26
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Insomnia: Baseline	31.7 scores on a scale Standard Deviation 34.12	36.5 scores on a scale Standard Deviation 31.46	30.3 scores on a scale Standard Deviation 32.38	20.6 scores on a scale Standard Deviation 26.82	38.3 scores on a scale Standard Deviation 29.17
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Insomnia: EOT	-16.7 scores on a scale Standard Deviation 23.57	-9.1 scores on a scale Standard Deviation 30.15	-16.7 scores on a scale Standard Deviation 33.33	-19.0 scores on a scale Standard Deviation 26.23	5.6 scores on a scale Standard Deviation 32.77
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Appetite Loss: Baseline	25.4 scores on a scale Standard Deviation 31.46	34.9 scores on a scale Standard Deviation 32.45	30.3 scores on a scale Standard Deviation 36.96	23.8 scores on a scale Standard Deviation 28.17	15.0 scores on a scale Standard Deviation 27.52
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Appetite Loss: EOT	16.7 scores on a scale Standard Deviation 23.57	0.0 scores on a scale Standard Deviation 53.75	16.7 scores on a scale Standard Deviation 43.03	33.3 scores on a scale Standard Deviation 47.14	16.7 scores on a scale Standard Deviation 34.96
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Constipation: Baseline	27.0 scores on a scale Standard Deviation 27.12	15.9 scores on a scale Standard Deviation 24.99	15.2 scores on a scale Standard Deviation 26.68	17.5 scores on a scale Standard Deviation 30.95	11.7 scores on a scale Standard Deviation 16.31
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Constipation: EOT	0.0 scores on a scale Standard Deviation 47.14	6.7 scores on a scale Standard Deviation 43.89	8.3 scores on a scale Standard Deviation 16.67	9.5 scores on a scale Standard Deviation 31.71	-5.6 scores on a scale Standard Deviation 13.61
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Diarrhoea: Baseline	17.5 scores on a scale Standard Deviation 30.95	9.5 scores on a scale Standard Deviation 26.13	18.2 scores on a scale Standard Deviation 24.62	18.3 scores on a scale Standard Deviation 31.48	8.3 scores on a scale Standard Deviation 14.81
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Diarrhoea: EOT	0.0 scores on a scale Standard Deviation 0.00	-3.0 scores on a scale Standard Deviation 34.82	0.0 scores on a scale Standard Deviation 27.22	23.8 scores on a scale Standard Deviation 25.20	27.8 scores on a scale Standard Deviation 32.77
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Financial Difficulties: Baseline	7.9 scores on a scale Standard Deviation 17.97	4.8 scores on a scale Standard Deviation 15.94	16.7 scores on a scale Standard Deviation 26.73	9.5 scores on a scale Standard Deviation 18.69	5.0 scores on a scale Standard Deviation 12.21
Quality of Life (QoL): Change From Baseline European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQC30) Scores Symptom Scales/Items/ Financial Difficulties: EOT	16.7 scores on a scale Standard Deviation 23.57	3.0 scores on a scale Standard Deviation 17.98	0.0 scores on a scale Standard Deviation 0.00	4.8 scores on a scale Standard Deviation 29.99	-5.6 scores on a scale Standard Deviation 13.61

SECONDARY outcome

Timeframe: From start of study treatment up to 30 days after the last dose administration (approximately 35 months)

Population: Analysis was performed on safety population that included all participants who had received any amount of study drug.

Clinically significant laboratory tests abnormalities were analyzed and reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=22 Participants Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 Participants Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 Participants Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Number of Participants With Individual Clinically Significant Abnormalities in Laboratory Tests	21 Participants	20 Participants	19 Participants	14 Participants	11 Participants

Adverse Events

Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW

Serious events: 14 serious events

Other events: 25 other events

Deaths: 21 deaths

Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW

Serious events: 14 serious events

Other events: 23 other events

Deaths: 20 deaths

Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW

Serious events: 6 serious events

Other events: 25 other events

Deaths: 23 deaths

Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW

Serious events: 12 serious events

Other events: 21 other events

Deaths: 20 deaths

Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW

Serious events: 12 serious events

Other events: 20 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 participants at risk Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 participants at risk Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Gastrointestinal disorders Vomiting	20.0% 5/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Ascites	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Ileus	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Nausea	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Anal Haemorrhage	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Constipation	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Haematemesis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Dehydration	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hyperglycaemia	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Bacteraemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Lung Infection	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Pneumonia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Urosepsis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Varicella Zoster Virus Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Escherichia Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Peritonitis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Respiratory Tract Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Urinary Tract Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Pyrexia	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Gait Disturbance	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Malaise	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Discomfort	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders General Physical Health Deterioration	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Inflammation	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Acute Kidney Injury	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Cystitis Noninfective	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Renal Failure	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Urinary Retention	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Anaemia	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Deep Vein Thrombosis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Embolism	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Cataract	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Vision Blurred	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Back Pain	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial Tumour Haemorrhage	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Aphasia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Cognitive Disorder	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Surgical and medical procedures Drain Placement	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.

Other adverse events

Other adverse events
Measure	Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW n=23 participants at risk Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW n=25 participants at risk Participants with cervical carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IV) disease received a dose of 50 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 12 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW n=21 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 35 mg/m\^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 50 mg/m\^2 of selinexor oral tablets BIW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.	Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW n=20 participants at risk Participants with ovarian carcinoma who were platinum refractory or platinum resistant and had received at least one line of chemotherapy for relapsed disease received a dose of 50 mg/m\^2 of selinexor oral tablets QW (doses at least 5 days apart) with light meal and 120 mL of water in a 4-week treatment cycles. After 6 weeks of treatment, a dose of 60 mg/m\^2 of selinexor oral tablets QW were administrated if the participants had no major toxicity. During dose reduction, participants received a minimum dose of 35 mg/m\^2 QW. This treatment continued until PD or unacceptable toxicity or any discontinuation criteria or withdrawal of consent by the participant, or non-compliance by the participant with protocol requirements.
Gastrointestinal disorders Nausea	88.0% 22/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	65.2% 15/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	68.0% 17/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	81.0% 17/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	75.0% 15/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Vomiting	72.0% 18/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	60.9% 14/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	44.0% 11/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	61.9% 13/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	60.0% 12/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Diarrhoea	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	30.4% 7/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	47.6% 10/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	40.0% 8/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Pain	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	23.8% 5/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	35.0% 7/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Distension	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Stomatitis	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Ascites	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	15.0% 3/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Dry Mouth	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	25.0% 5/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Defaecation Urgency	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Oesophageal Irritation	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Oesophageal Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Oral Mucosal Blistering	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Fatigue	48.0% 12/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	65.2% 15/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	60.0% 15/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	66.7% 14/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	70.0% 14/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Asthenia	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	30.4% 7/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 5/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	28.6% 6/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	15.0% 3/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Malaise	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	13.0% 3/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Pyrexia	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Oedema Peripheral	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	28.6% 6/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Face Oedema	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders General Physical Health Deterioration	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Oedema	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
General disorders Chills	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Decreased Appetite	48.0% 12/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	78.3% 18/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	48.0% 12/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	76.2% 16/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	50.0% 10/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hypokalaemia	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	34.8% 8/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	23.8% 5/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	21.7% 5/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	15.0% 3/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hyponatraemia	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	21.7% 5/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hyperglycaemia	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	17.4% 4/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Anaemia	52.0% 13/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	47.8% 11/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	56.0% 14/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	42.9% 9/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	25.0% 5/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Thrombocytopenia	48.0% 12/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	43.5% 10/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	52.0% 13/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	19.0% 4/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Blood and lymphatic system disorders Neutropenia	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	13.0% 3/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Dysgeusia	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	21.7% 5/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	44.0% 11/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	19.0% 4/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	30.0% 6/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Dizziness	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	21.7% 5/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	19.0% 4/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Peripheral Sensory Neuropathy	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	17.4% 4/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	15.0% 3/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Headache	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Paraesthesia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Somnolence	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Syncope	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Nervous system disorders Aphasia	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Investigations Weight Decreased	48.0% 12/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	56.5% 13/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	72.0% 18/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	52.4% 11/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	30.0% 6/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Urinary Tract Infection	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Cystitis	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	13.0% 3/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Lung Infection	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Laryngitis	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Pneumonia	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Bronchitis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Oral Candidiasis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Helicobacter Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Herpes Simplex	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Peritonitis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Respiratory Tract Infection	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Vision Blurred	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	34.8% 8/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 5/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	33.3% 7/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	25.0% 5/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Visual Impairment	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Cataract	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	13.0% 3/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	33.3% 7/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Cough	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	25.0% 5/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Back Pain	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	13.0% 3/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 4/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Muscular Weakness	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Muscle Spasms	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Insomnia	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	20.0% 5/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Anxiety	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Confusional State	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Depression	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Hallucination	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Psychiatric disorders Agitation	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Dysuria	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Haematuria	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	12.0% 3/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Pollakiuria	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	16.0% 4/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Hydronephrosis	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Skin and subcutaneous tissue disorders Alopecia	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Skin and subcutaneous tissue disorders Skin Fissures	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	9.5% 2/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Hypotension	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Hot Flush	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	10.0% 2/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Deep Vein Thrombosis	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	14.3% 3/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Vascular disorders Hypertension	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Ear and labyrinth disorders Ear Discomfort	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Ear and labyrinth disorders Vertigo	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Ear and labyrinth disorders Auditory Disorder	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.7% 2/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Injury, poisoning and procedural complications Contusion	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Reproductive system and breast disorders Vaginal Haemorrhage	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Product Issues Device Occlusion	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	8.0% 2/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Eye disorders Dry Eye	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.8% 1/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Gastrointestinal disorders Constipation	28.0% 7/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	26.1% 6/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	24.0% 6/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	52.4% 11/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	35.0% 7/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Infections and infestations Device Related Infection	4.0% 1/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.
Renal and urinary disorders Polyurea	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	4.3% 1/23 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/25 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	0.00% 0/21 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.	5.0% 1/20 • From start of study treatment up to 30 days after last dose administration (approximately 35 months) Analysis was performed on safety population that included all participants who had received any amount of study medication.

Additional Information

Jatin Shah, MD

Karyopharm Therapeutics Inc.

Phone: (617) 658-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place