Trial Outcomes & Findings for LY3214996 +/- HCQ in Pancreatic Cancer (NCT NCT04386057)

Last Updated: 2025-02-12

Results Overview

Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

28 Months

Results posted on

2025-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Overall Study STARTED	7	6	20	16	3
Overall Study COMPLETED	7	6	20	16	3
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LY3214996 +/- HCQ in Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination n=20 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy n=16 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm n=3 Participants Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	16 Participants n=8 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants	3 Participants n=21 Participants	36 Participants n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	19 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	2 Participants n=21 Participants	33 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	2 Participants n=21 Participants	47 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	3 Participants n=21 Participants	43 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	20 participants n=5 Participants	16 participants n=4 Participants	3 participants n=21 Participants	52 participants n=8 Participants

PRIMARY outcome

Timeframe: 28 Months

Outcome measures

Outcome measures
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination n=20 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy n=16 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm n=3 Participants Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Disease Control Rate (DCR)	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 Days

Dose Limiting Toxicity-Lead In

Outcome measures

Outcome measures
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Dose Limiting Toxicity-Lead In	2 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 28 Months

Objective response rate (ORR) is defined as the number of participants who had a complete or partial response at any time during treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination n=20 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy n=16 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm n=3 Participants Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Objective Response Rate (ORR)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation up to 28 Months

Population: PFS (months) was calculated for participants only in the randomized arms (including crossovers in their original arm) as an Intention to Treat Analysis (ITT). Analyses were not completed for participants in the safety lead-in cohort, as this cohort was intended to evaluate safety only; not efficacy. Only 14 participants were evaluable for PFS in Arm A and 17 were evaluable in Arm B. These numbers differ slightly to the overall number of participants due to missing data and adding crossovers.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study . The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesion and/or unequivocal progression of existing non-target lesions are also considered progression. Unequivocal progression should not normally trump target lesion status and must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Outcome measures
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=14 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=17 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Progression-free Survival (PFS)	1.3 months Interval 0.8 to 1.8	1.9 months Interval 1.6 to 2.4	—	—	—

SECONDARY outcome

Timeframe: Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive. OS was calculated for a median of 115 days, ranging from 18 - 327 days.

Population: OS (months) was calculated for participants only in the randomized arms (including crossovers in their original arm) as an Intention to Treat Analysis (ITT). Analyses were not completed for participants in the safety lead-in cohort, as this cohort was intended to evaluate safety only; not efficacy. Only 17 participants were evaluable from Arm A and 19 were evaluable from Arm B. These numbers differ slightly to the overall number of participants due to missing data and adding crossovers.

Kaplan and Meier to assess Overall survival (OS)

Outcome measures

Outcome measures
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=17 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=19 Participants The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Overall Survival (OS)	2.4 months Interval 1.3 to 5.8	4.7 months Interval 3.1 to 5.7	—	—	—

Adverse Events

Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 7 deaths

Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

LY3214996 and HCQ Combination

Serious events: 6 serious events

Other events: 16 other events

Deaths: 18 deaths

LY3214996-Monotherapy

Serious events: 4 serious events

Other events: 16 other events

Deaths: 13 deaths

Cross Over Arm

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination n=20 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy n=16 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm n=3 participants at risk Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Gastrointestinal disorders Abdominal pain	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Renal and urinary disorders Acute kidney injury	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Blood bilirubin increased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Chills	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Cognitive disturbance	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Psychiatric disorders Confusion	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Constipation	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations CPK increased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Death NOS	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Dehydration	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Diarrhea	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Disease progression	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Fatigue	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Fever	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Gait disturbance	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypercalcemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypoalbuminemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Injury, poisoning and procedural complications Intestinal stoma site bleeding	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Nausea	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Pain	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Psychiatric disorders Psychiatric disorders - Other, specify	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Somnolence	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Stroke	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Vascular disorders Thromboembolic event	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.

Other adverse events

Other adverse events
Measure	Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996) n=7 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level 0 will have a 400mg LY3214996 dose.	Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996) n=6 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle. All dose levels will have a 400mg HCQ dose. LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle. Dose level -1 will have a 200mg LY3214996 dose.	LY3214996 and HCQ Combination n=20 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	LY3214996-Monotherapy n=16 participants at risk The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle	Cross Over Arm n=3 participants at risk Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ Hydroxychloroquine Sulfate: HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle LY3214996: LY3214996-daily oral dosage per protocol per 28 day cycle
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	35.0% 7/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	37.5% 6/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	100.0% 3/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Acidosis	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	35.0% 7/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	56.2% 9/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Alkaline phosphatase increased	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	40.0% 8/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	25.0% 4/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Immune system disorders Allergic reaction	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Blood and lymphatic system disorders Anemia	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	45.0% 9/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 8/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 4/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	35.0% 7/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	31.2% 5/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Psychiatric disorders Anxiety	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Ascites	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Aspartate aminotransferase increased	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 3/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	30.0% 6/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 8/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Belching	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Bloating	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Blood bilirubin increased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	31.2% 5/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Eye disorders Blurred vision	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Cardiac troponin T increased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Chills	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Hepatobiliary disorders Cholecystitis	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Cognitive disturbance	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Psychiatric disorders Confusion	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Constipation	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 4/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	56.2% 9/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations CPK increased	57.1% 4/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Creatinine increased	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	31.2% 5/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Dehydration	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	18.8% 3/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Diarrhea	42.9% 3/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	43.8% 7/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Dizziness	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Dysarthria	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Dysgeusia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Dysphagia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Edema limbs	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	25.0% 5/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Facial muscle weakness	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Injury, poisoning and procedural complications Fall	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Fatigue	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	83.3% 5/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	55.0% 11/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	62.5% 10/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Fever	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	25.0% 4/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Flatulence	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Eye disorders Floaters	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Gastroesophageal reflux disease	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Generalized edema	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	31.2% 5/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Headache	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Vascular disorders Hot flashes	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	18.8% 3/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hyperphosphatemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Vascular disorders Hypertension	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypoalbuminemia	57.1% 4/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 3/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	35.0% 7/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	37.5% 6/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	31.2% 5/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypomagnesemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hyponatremia	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	45.0% 9/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	37.5% 6/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Hypophosphatemia	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Vascular disorders Hypotension	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Endocrine disorders Hypothyroidism	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Psychiatric disorders Insomnia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Investigations - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Lymphocyte count decreased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	37.5% 6/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Mucositis oral	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Nausea	57.1% 4/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 3/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	60.0% 12/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	75.0% 12/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	100.0% 3/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Neutrophil count decreased	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Night sweats	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Obstruction gastric	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Oral pain	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
General disorders Pain	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Papulopustular rash	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Paresthesia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Eye disorders Periorbital edema	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 2/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Platelet count decreased	57.1% 4/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	20.0% 4/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	62.5% 10/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	66.7% 2/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Rash acneiform	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	18.8% 3/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	25.0% 4/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Rash pustular	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Sepsis	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Cardiac disorders Sinus tachycardia	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Nervous system disorders Somnolence	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Stomach pain	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Vascular disorders Thromboembolic event	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Thrush	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Renal and urinary disorders Urinary incontinence	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Renal and urinary disorders Urinary retention	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	5.0% 1/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Infections and infestations Urinary tract infection	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	15.0% 3/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	6.2% 1/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Gastrointestinal disorders Vomiting	28.6% 2/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	35.0% 7/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	50.0% 8/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Weight gain	14.3% 1/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations Weight loss	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	10.0% 2/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	12.5% 2/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	33.3% 1/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.
Investigations White blood cell decreased	0.00% 0/7 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	16.7% 1/6 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/20 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/16 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.	0.00% 0/3 • Adverse Events were reviewed between the initial dose of study treatment (first patient treated June 2020) and 30 days of the last dose of treatment (last patient September 2023). Participants were assessed for AEs for a median of 67 days (range 31-141 days). All-cause mortality was assessed from date of randomization to death of any cause or last known date alive, for a median of 115 days (range 18-327 days). After completion of the 30 day follow up period, participants will continue to be followed for 6 months after removal of protocol therapy or until death for survival status only. Considering this, the total length of study differs from the total adverse event collection time frame.

Additional Information

Dr. Kimberly Perez, MD

Dana-Farber Cancer Institute

Phone: 617-632-5370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place