Trial Outcomes & Findings for A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma (NCT NCT04421378)

Last Updated: 2024-12-16

Results Overview

MTD was defined as highest dose of selinexor in at which no more than one of six participants experienced a dose-limiting toxicity (DLT). DLT was based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

74 participants

Primary outcome timeframe

At Cycle 1 (up to 42 days)

Results posted on

2024-12-16

Participant Flow

This study was conducted at 18 sites in the United States and Canada. This study had three phases: Phase 1a, Phase 1b and Phase 2. The study was early terminated during the Phase 1b portion of the study as the initial responses to selinexor treatment were not supportive of continued investigation in glioblastoma, therefore Phase 2 data could not be collected and there was no reporting of the Phase 2 data in this report.

Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

Participant milestones

Participant milestones
Measure	Arm A: Selinexor + Radiation Therapy Participants with newly diagnosed glioblastoma (nGBM) unmethylated O6-methylguanine-DNA-methyltransferase (uMGMT) received 60 to 80 milligrams (mg) of selinexor oral tablet, once weekly (QW) in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently continued at 80 mg of selinexor, QW until progressive disease (PD) during adjuvant therapy period.	Arm B: Selinexor + Temozolomide + Radiation Therapy Participants with nGBM methylated O6-methylguanine-DNA-methyltransferase (mMGMT) received 40 to 80 mg of selinexor oral tablet, QW and 75 milligrams per sqaure meter (mg/m\^2) of temozolomide oral capsule, once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine Participants with recurrent glioblastoma (rGBM) uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab intravenous (IV), infusion every 2 weeks (Q2W) in each 28-day cycle until PD, unacceptable adverse events (AEs) or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kilohertz (kHz) of transducer array greater than or equal to (\>=) 18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Overall Study STARTED	23	15	19	14	3
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	23	15	19	14	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Selinexor + Radiation Therapy Participants with newly diagnosed glioblastoma (nGBM) unmethylated O6-methylguanine-DNA-methyltransferase (uMGMT) received 60 to 80 milligrams (mg) of selinexor oral tablet, once weekly (QW) in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently continued at 80 mg of selinexor, QW until progressive disease (PD) during adjuvant therapy period.	Arm B: Selinexor + Temozolomide + Radiation Therapy Participants with nGBM methylated O6-methylguanine-DNA-methyltransferase (mMGMT) received 40 to 80 mg of selinexor oral tablet, QW and 75 milligrams per sqaure meter (mg/m\^2) of temozolomide oral capsule, once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine Participants with recurrent glioblastoma (rGBM) uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab intravenous (IV), infusion every 2 weeks (Q2W) in each 28-day cycle until PD, unacceptable adverse events (AEs) or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kilohertz (kHz) of transducer array greater than or equal to (\>=) 18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Overall Study Adverse Event	2	7	0	1	0
Overall Study Physician Decision	1	2	0	0	0
Overall Study Progressive Disease	16	4	18	11	3
Overall Study Study Terminated by Sponsor	0	1	1	0	0
Overall Study Withdrawal by Subject	3	1	0	2	0
Overall Study Other	1	0	0	0	0

Baseline Characteristics

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Selinexor + Radiation Therapy n=23 Participants Participants with nGBM uMGMT received 60 to 80 mg of selinexor oral tablet, once QW in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently continued at 80 mg of selinexor, QW until PD during adjuvant therapy period.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Total n=74 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 13.84 • n=99 Participants	53.3 years STANDARD_DEVIATION 14.88 • n=107 Participants	59.2 years STANDARD_DEVIATION 10.22 • n=206 Participants	59.0 years STANDARD_DEVIATION 10.50 • n=7 Participants	53.3 years STANDARD_DEVIATION 2.52 • n=31 Participants	57.7 years STANDARD_DEVIATION 12.69 • n=30 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants	4 Participants n=7 Participants	1 Participants n=31 Participants	32 Participants n=30 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	8 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=7 Participants	2 Participants n=31 Participants	42 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	4 Participants n=7 Participants	1 Participants n=31 Participants	14 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants	13 Participants n=107 Participants	17 Participants n=206 Participants	10 Participants n=7 Participants	2 Participants n=31 Participants	59 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	4 Participants n=30 Participants
Race (NIH/OMB) White	23 Participants n=99 Participants	12 Participants n=107 Participants	16 Participants n=206 Participants	13 Participants n=7 Participants	3 Participants n=31 Participants	67 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	2 Participants n=30 Participants

PRIMARY outcome

Timeframe: At Cycle 1 (up to 42 days)

Population: The dose escalation population consisted of all participants in the Dose Escalation Phase who have either had a DLT prior to completion of 1 cycle of therapy, or who had completed a cycle of therapy. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=74 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Maximum Tolerated Dose of Selinexor	60 milligrams per week	—	—	—	—

PRIMARY outcome

Timeframe: From Cycle 1 Day 1 up to 14 days after last dose (up to 15.41 months) (Each Cycle length = up to 42 days)

The RP2D was determined by SRC, based on the MTD and the totality of efficacy and safety data of Phase 1a dose escalation study. RP2D was determined based on the totality of the available safety, efficacy, pharmacokinetic/pharmacodynamic (PK/PD).

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Recommended Phase 2 Dose (RP2D) of Selinexor	80 milligrams per week	NA milligrams per week Here 'NA' means RP2D could not be determined as Arm B was still in dose finding when the study terminated.	NA milligrams per week Here 'NA' means RP2D could not be determined as Arm C was still in dose finding when the study terminated.	80 milligrams per week	NA milligrams per week Here 'NA' means RP2D could not be determined as the number of participants was considered too small for any definitive conclusions.

PRIMARY outcome

Timeframe: From first dose of study treatment up to 30 days post last dose (Up to 16.41 months)

Population: The safety population consisted of participants in Phase 1a and Phase 1b who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

TEAE: any event that was not present prior to initiation of study treatment or any event already present that worsened in either intensity or frequency following exposure to study treatment. Serious adverse event (SAE): any untoward medical occurrence that, at any dose, resulted in death; was life threatening (i.e., an event in which participant was at risk of death at the time of the event; it did not refer to an event that hypothetically might have caused death if it were more severe); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect. Important medical events that might not result in death, was life-threatening, or require hospitalization might be considered serious when, based upon appropriate medical judgment, they might jeopardize participant and might require medical or surgical intervention to prevent one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) With Grade Greater Than or Equal to (>=) 3, Serious TEAEs and Who Discontinued Treatment Due to TEAEs Participants with Grade >=3 TEAEs	15 Participants	12 Participants	16 Participants	8 Participants	1 Participants
Phase 1a and 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) With Grade Greater Than or Equal to (>=) 3, Serious TEAEs and Who Discontinued Treatment Due to TEAEs Participants with Serious TEAEs	6 Participants	5 Participants	6 Participants	3 Participants	1 Participants
Phase 1a and 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) With Grade Greater Than or Equal to (>=) 3, Serious TEAEs and Who Discontinued Treatment Due to TEAEs Participants who Discontinued Treatment Due to TEAEs	2 Participants	7 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: At 3 Months

Population: The modified Intent-to-Treat (mITT) population consisted of participants in Phase 1a and Phase 1b who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

Progression defined as first occurrence of disease progression (PD) per modified Response Assessment in Neuro-Oncology (RANO) including both radiological PD and clinical deterioration. PD per RANO response criteria:1) At least two sequential scans separated by at \>=4 weeks both exhibiting \>=25 percent (%) increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions. 2) In case where baseline or best response demonstrates no measurable enhancing disease, then any new measurable (\>10mm\*10mm) enhancing lesions considered PD after confirmed by a subsequent scan \>=4 weeks exhibiting \>=25% increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions relative to scan first illustrating new measurable disease. 3) Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid dose. 4) Failure to return for evaluation as a result of death.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Percentage of Participants With Progression Free Survival at 3 Months	69.6 percentage of participants	66.7 percentage of participants	21.1 percentage of participants	57.1 percentage of participants	33.3 percentage of participants

PRIMARY outcome

Timeframe: From date of randomization to the date of death due to any cause or until lost to follow-up (up to 20 months)

Population: The mITT population consisted of participants in Phase 1a and Phase 1b who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

OS was defined as the time from the date of randomization until death due to any cause or until lost to follow-up for all participants.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Overall Survival (OS)	13.54 months Interval 11.37 to 18.23	19.78 months Interval 13.5 to Here, NA means data could not be determined due to insufficient events.	8.34 months Interval 7.13 to 12.75	8.80 months Interval 6.05 to Here, NA means data could not be determined due to insufficient events.	14.36 months Interval 7.2 to Here, NA means data could not be determined due to insufficient events.

SECONDARY outcome

Timeframe: From first dose study treatment until progression or death due to progression (Up to 15.41 months)

TTP was defined for participants as the duration from start of treatment to the date of PD, or death due to PD, whichever occurs first. PD per RANO response criteria: 1) At least two sequential scans separated by at \>=4 weeks both exhibiting \>=25 percent (%) increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions. 2) In case where baseline or best response demonstrates no measurable enhancing disease, then any new measurable (\>10mm\*10mm) enhancing lesions considered PD after confirmed by a subsequent scan \>=4 weeks exhibiting \>=25% increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions relative to scan first illustrating new measurable disease. 3) Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid dose. 4) Failure to return for evaluation as a result of death or deteriorating condition.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Time to Progression (TTP)	8.11 months Interval 6.05 to 11.5	NA months Interval 11.37 to Here, NA means data could not be determined due to insufficient events.	1.38 months Interval 1.22 to 4.07	4.60 months Interval 2.53 to Here, NA means data could not be determined due to insufficient events.	1.71 months Interval 1.64 to Here, NA means data could not be determined due to insufficient events.

SECONDARY outcome

Timeframe: From first dose of study treatment until progression or death due to any cause (Up to 15.41 months)

Progression defined as first occurrence of PD per modified RANO including both radiological PD and clinical deterioration. PD per RANO response criteria: 1) At least two sequential scans separated by at \>=4 weeks both exhibiting \>=25 percent (%) increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions. 2) In case where baseline or best response demonstrates no measurable enhancing disease, then any new measurable (\>10mm\*10mm) enhancing lesions considered PD after confirmed by a subsequent scan \>=4 weeks exhibiting \>=25% increase in sum of products of perpendicular diameters or \>=40% increase in total volume of enhancing lesions relative to scan first illustrating new measurable disease. 3) Clear clinical deterioration not attributable to other causes apart from tumor or attributable to changes in steroid dose. 4) Failure to return for evaluation as a result of death or deteriorating condition.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=23 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 Participants Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Progressive Free Survival (PFS)	8.11 months Interval 6.05 to 11.5	NA months Interval 11.37 to Here, NA means data could not be determined due to insufficient events.	1.38 months Interval 1.22 to 4.07	4.60 months Interval 2.53 to Here, NA means data could not be determined due to insufficient events.	1.71 months Interval 1.64 to Here, NA means data could not be determined due to insufficient events.

SECONDARY outcome

Timeframe: From first dose of study treatment until death due to any cause (Up to 15.41 months)

ORR was defined as percentage of participants who achieve a CR or PR per modified RANO criteria. CR defined as that meet all following: 1) Disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. 2) No new lesions. 3) Participants must be off corticosteroids (or on physiologic replacement doses only). 4) Stable or improved clinical assessments (i.e., neurological examinations). PR defined as that meet all following: 1) \>=50% decrease in sum of products of perpendicular diameters or \>=65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks. 2) No new lesion. 3. Steroid dose should be the same or lower compared with baseline scan. 4) Stable or improved clinical assessments.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=19 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=14 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=3 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Overall Response Rate (ORR) Based on Modified Response Assessment in Neuro-Oncology (RANO) Criteria in Arm C, D and E	10.5 percentage of participants Interval 1.3 to 33.1	35.7 percentage of participants Interval 12.8 to 64.9	0 percentage of participants Here, NA means data could not be determined due to insufficient events.	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment until death due to any cause (Up to 15.41 months)

DCR: percentage of participants who achieve CR, PR, or stable disease (SD) per modified RANO criteria. CR: 1) Disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. 2) No new lesions. 3) Participants must be off corticosteroids. 4) Stable or improved clinical assessments. PR: 1) \>=50% decrease in sum of products of perpendicular diameters or \>=65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks. 2) No new lesion. 3) Steroid dose should be same or lower compared with baseline scan. 4) Stable or improved clinical assessments. SD: 1) Does not qualify for CR, PR, or PD. 2) In event that corticosteroid dose was increased without confirmation of PD on neuroimaging, and subsequent follow-up imaging shows steroid increase was required because of PD, last scan considered to show SD was scan obtained when corticosteroid dose was equivalent to baseline dose.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=19 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=14 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=3 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Disease Control Rate (DCR) Based on Modified Response Assessment in Neuro-Oncology (RANO) Criteria in Arm C, D and E	21.1 percentage of participants Interval 6.1 to 45.6	57.1 percentage of participants Interval 28.9 to 82.3	0 percentage of participants Here, NA means data could not be determined due to insufficient events.	—	—

SECONDARY outcome

Timeframe: From the date of first evidence of objective response until progression (Up to 15.41 months)

Population: The mITT population. Here, "overall number of participants analyzed" signifies those participants who had CR or PR. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

DOR was defined as the time from the date of first evidence of objective response (CR or PR) until PD. CR defined as that meet all following: 1) Disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. 2) No new lesions. 3) Participants must be off corticosteroids (or on physiologic replacement doses only). 4) Stable or improved clinical assessments (i.e., neurological examinations). PR defined as that meet all following: 1) \>=50% decrease in sum of products of perpendicular diameters or \>=65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks. 2) No new lesion. 3. Steroid dose should be the same or lower compared with baseline scan. 4) Stable or improved clinical assessments. DOR was analyzed by Kaplan-Meier for participants who have achieved overall response (CR or PR).

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=2 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=5 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Duration of Response (DOR) in Arm C, D and E	NA months Interval 3.02 to Here, NA means data could not be determined due to insufficient events.	3.52 months Interval 2.79 to Here, NA means data could not be determined due to insufficient events.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 2, 4, and 6 hours post-dose (Cycle 1 length = up to 42 days)

Population: PK analysis set. Here, "overall number of participants analyzed" signifies those participants who are evaluable for this outcome. Due to the early study termination and pre-specified analysis, data was collected/reported for Cmax was calculated across treatment for each patient per dose level (40 mg, 60 mg and 80 mg) considering no accumulation of selinexor.

Cmax of Selinexor was reported.

Outcome measures

Outcome measures
Measure	Arms A+B+C+D+E: Selinexor n=3 Participants All participants who received 40 to 80 mg or 60 to 80 mg of selinexor oral tablet, QW in each 28-day cycle until PD.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=5 Participants Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=23 Participants Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Phase 1a and 1b: Maximum Plasma Concentration (Cmax) of Selinexor	306 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.8	490 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.9	607 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.3	—	—

Adverse Events

Arm A: Selinexor + Radiation Therapy

Serious events: 6 serious events

Other events: 23 other events

Deaths: 15 deaths

Arm B: Selinexor + Temozolomide + Radiation Therapy

Serious events: 5 serious events

Other events: 15 other events

Deaths: 7 deaths

Arm C: Selinexor + Lomustine/Carmustine

Serious events: 6 serious events

Other events: 19 other events

Deaths: 15 deaths

Arm D: Selinexor + Bevacizumab

Serious events: 3 serious events

Other events: 14 other events

Deaths: 11 deaths

Arm E: Selinexor + Tumor Treating Fields

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Selinexor + Radiation Therapy n=23 participants at risk Participants with nGBM uMGMT received 60 to 80 mg of selinexor oral tablet, once QW in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently continued at 80 mg of selinexor, QW until PD during adjuvant therapy period.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 participants at risk Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 participants at risk Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 participants at risk Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 participants at risk Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Cerebrovascular accident	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Hemiparesis	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Seizure	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Agitation	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Cellulitis	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Vascular disorders Deep vein thrombosis	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Dehydration	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Dizziness	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Escherichia urinary tract infection	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Fall	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Headache	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Hydrocephalus	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Nausea	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
General disorders Non-cardiac chest pain	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Overdose	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Cardiac disorders Sinus bradycardia	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Sinusitis	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Urinary tract infection	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Urosepsis	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Vomiting	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations COVID-19	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Postoperative wound infection	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

Other adverse events

Other adverse events
Measure	Arm A: Selinexor + Radiation Therapy n=23 participants at risk Participants with nGBM uMGMT received 60 to 80 mg of selinexor oral tablet, once QW in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently continued at 80 mg of selinexor, QW until PD during adjuvant therapy period.	Arm B: Selinexor + Temozolomide + Radiation Therapy n=15 participants at risk Participants with nGBM mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 75 mg/m\^2 of temozolomide oral capsule, QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg or 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 of temozolomide oral capsule and increase to 200 mg/m\^2, daily for 5 days in a 28-day cycle during Cycle 3 to 8 during adjuvant therapy period. Participants continued selinexor weekly until PD.	Arm C: Selinexor + Lomustine/Carmustine n=19 participants at risk Participants with rGBM uMGMT or mMGMT received 40 to 80 mg of selinexor oral tablet, QW and 90 to 110 mg/m\^2 of lomustine or 150 to 200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each 42-days cycle for up to 6 cycles. Participants continued selinexor weekly until PD.	Arm D: Selinexor + Bevacizumab n=14 participants at risk Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and 10 mg/kg of Bevacizumab IV, infusion Q2W in each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.	Arm E: Selinexor + Tumor Treating Fields n=3 participants at risk Participants with rGBM received 60 to 80 mg of selinexor oral tablet, QW and received scalp application of 200 kHz of transducer array \>=18 hours per day daily for each 28-day cycle until PD, unacceptable AEs or failure to tolerate the study treatment, treatment delay of more than 28 days (except in specific cases with documented approval from the Sponsor), any medically appropriate reason or significant protocol violation (in the opinion of the Investigator), or participant decided to discontinue study treatment, withdraws consent, or became pregnant.
Blood and lymphatic system disorders Neutropenia	52.2% 12/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	73.3% 11/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	57.9% 11/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	42.9% 6/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Thrombocytopenia	26.1% 6/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	66.7% 10/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	78.9% 15/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	50.0% 7/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Lymphopenia	34.8% 8/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	60.0% 9/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	52.6% 10/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.4% 3/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Leukopenia	34.8% 8/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	42.1% 8/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	57.1% 8/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Blood and lymphatic system disorders Anaemia	39.1% 9/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	40.0% 6/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	36.8% 7/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Cardiac disorders Sinus bradycardia	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Cardiac disorders Sinus tachycardia	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Eye disorders Vision blurred	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Nausea	60.9% 14/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	60.0% 9/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	36.8% 7/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	50.0% 7/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Constipation	52.2% 12/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	46.7% 7/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	15.8% 3/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Vomiting	34.8% 8/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	31.6% 6/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Diarrhoea	21.7% 5/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	26.7% 4/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
General disorders Fatigue	91.3% 21/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	93.3% 14/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	73.7% 14/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	42.9% 6/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	66.7% 2/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
General disorders Gait disturbance	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.1% 4/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.4% 3/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
General disorders Oedema peripheral	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.1% 4/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	66.7% 2/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations COVID-19	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Infections and infestations Skin infection	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Fall	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.1% 4/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Contusion	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Injury, poisoning and procedural complications Radiation skin injury	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Investigations Weight decreased	43.5% 10/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Investigations Alanine aminotransferase increased	17.4% 4/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	15.8% 3/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.4% 3/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Investigations Aspartate aminotransferase increased	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.1% 4/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Investigations Blood creatinine increased	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Investigations Weight increased	43.5% 10/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Decreased appetite	43.5% 10/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Hypokalaemia	30.4% 7/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Hyponatraemia	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	28.6% 4/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Dehydration	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Metabolism and nutrition disorders Hyperglycaemia	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Musculoskeletal and connective tissue disorders Muscular weakness	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Musculoskeletal and connective tissue disorders Back pain	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Seizure	26.1% 6/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	15.8% 3/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Hemiparesis	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	26.3% 5/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	21.4% 3/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Headache	26.1% 6/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 5/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Dysgeusia	17.4% 4/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Facial paresis	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Aphasia	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Cognitive disorder	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Dizziness	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Memory impairment	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Dysarthria	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Nervous system disorders Somnolence	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Psychiatric disorders Depression	21.7% 5/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Psychiatric disorders Confusional state	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	14.3% 2/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Psychiatric disorders Agitation	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Psychiatric disorders Anxiety	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Renal and urinary disorders Urinary retention	8.7% 2/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	20.0% 3/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.0% 3/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Skin and subcutaneous tissue disorders Alopecia	39.1% 9/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	26.7% 4/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Vascular disorders Hypertension	21.7% 5/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	13.3% 2/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	10.5% 2/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	33.3% 1/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.
Vascular disorders Hypotension	4.3% 1/23 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	6.7% 1/15 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	5.3% 1/19 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	7.1% 1/14 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.	0.00% 0/3 • From first dose of study treatment up to 30 days post last dose (Up to 20 months) The safety population consisted of participants who have been assigned to study intervention and who have received \>=1 dose of study drug. Due to the early study termination and pre-specified analysis, data was collected/reported according to disease characteristics and combined dose range (60 to 80 mg or 40 to 80 mg) participants received regardless of study phase. The 'per arm' or 'per dose level' data was not collected.

Additional Information

Karyopharm Medical Information

Karyopharm Therapeutics Inc

Phone: (888) 209-9326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER