Trial Outcomes & Findings for The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer (NCT NCT03414658)

Last Updated: 2025-07-02

Results Overview

Progression Free Survival is defined from the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs first.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

2 years

Results posted on

2025-07-02

Participant Flow

AVIATOR enrolled 100 patients in 16 centers in the US between June 21, 2018 and March 1, 2023.

Participant milestones

Participant milestones
Measure	NH: Trastuzumab + Vinorelbine * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Study STARTED	20	46	34
Overall Study COMPLETED	18	45	34
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NH: Trastuzumab + Vinorelbine n=18 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells	Total n=97 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	53 years n=7 Participants	57 years n=5 Participants	54 years n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	45 Participants n=7 Participants	33 Participants n=5 Participants	96 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	38 Participants n=7 Participants	31 Participants n=5 Participants	87 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 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
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	31 Participants n=7 Participants	26 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	45 participants n=7 Participants	34 participants n=5 Participants	97 participants n=4 Participants
ECOG PS 0	11 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	58 Participants n=4 Participants
ECOG PS 1	7 Participants n=5 Participants	21 Participants n=7 Participants	11 Participants n=5 Participants	39 Participants n=4 Participants
BMI	23.8 kg/m^2 n=5 Participants	24.9 kg/m^2 n=7 Participants	26.4 kg/m^2 n=5 Participants	25.2 kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	NH: Trastuzumab + Vinorelbine n=18 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Progression Free Survival	2 months Interval 1.7 to 3.9	3.8 months Interval 3.0 to 5.5	4.9 months Interval 3.7 to 5.5

SECONDARY outcome

Timeframe: 2 years

Objective Response Rate is determined by Complete Response or Partial Response by RECIST 1.1. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	NH: Trastuzumab + Vinorelbine n=18 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Objective Response Rate	11.1 percent of participants Interval 2.0 to 31.0	20 percent of participants Interval 10.9 to 32.3	11.8 percent of participants Interval 4.1 to 24.9

SECONDARY outcome

Timeframe: 3 years

Population: Participants who had response.

Duration of Response is measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Per RECIST 1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	NH: Trastuzumab + Vinorelbine n=2 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=9 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=4 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Duration of Response	NA months Values are NA due to insufficient number of participants with events: only 2 patients had response in NH arm. The DOR of them are 4 and 10.3 months.	15.8 months Interval 3.6 to 25.2	4.2 months Interval 3.0 to 90% UCL could not be estimated due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: 5 years

Overall survival is defined as the time from randomization to death from any cause, or is censored at date last known alive.

Outcome measures

Outcome measures
Measure	NH: Trastuzumab + Vinorelbine n=18 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 Participants * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Overall Survival	22.8 months Interval 17.4 to 90% UCL could not be estimated due to insufficient number of participants with events.	26.3 months Interval 15.9 to 36.1	27 months Interval 17.3 to 33.7

Adverse Events

NH: Trastuzumab + Vinorelbine

Serious events: 5 serious events

Other events: 18 other events

Deaths: 10 deaths

NHA: Trastuzumab + Vinorelbine + Avelumab

Serious events: 9 serious events

Other events: 45 other events

Deaths: 23 deaths

NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab

Serious events: 9 serious events

Other events: 34 other events

Deaths: 20 deaths

Serious adverse events

Other adverse events

Additional Information

Adrienne G. Waks, MD

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	NH: Trastuzumab + Vinorelbine n=18 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
General disorders Death NOS	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
General disorders Fever	11.1% 2/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Infections and infestations Skin infection	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Infections and infestations Lung infection	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Investigations Neutrophil count decreased	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	4.4% 2/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Endocrine disorders Adrenal insufficiency	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Constipation	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Nausea	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Obstruction gastric	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
General disorders Pain	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Infections and infestations Urinary tract infection	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Investigations Lipase increased	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Investigations Serum amylase increased	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Investigations White blood cell decreased	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Reproductive system and breast disorders Breast pain	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Vascular disorders Thromboembolic event	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Hepatobiliary disorders Gallbladder perforation	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Infections and infestations Abdominal infection	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Infections and infestations Sinusitis	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Investigations Blood bilirubin increased	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Psychiatric disorders Confusion	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Renal and urinary disorders Acute kidney injury	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).

Other adverse events
Measure	NH: Trastuzumab + Vinorelbine n=18 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.	NHA: Trastuzumab + Vinorelbine + Avelumab n=45 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein	NHAU: Trastuzumab + Vinorelbine + Avelumab + Utomilumab n=34 participants at risk * Trastuzumab is administered intravenously twice per cycle * Vinorelbine is administered intravenously 3 times per cycle * Avelumab is administered intravenously twice per cycle * Antihistamine and with acetaminophen is mandatory 30 to 60 minutes prior to each dose of avelumab * Utomilumab is administered intravenously once per cycle Vinorelbine: work by interfering with cell division, which leaves the tumor unable to grow and spread Trastuzumab: trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2. Avelumab: monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein Utomilumab: Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
Blood and lymphatic system disorders Anemia	61.1% 11/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	37.8% 17/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	44.1% 15/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Blood and lymphatic system disorders Leukocytosis	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Cardiac disorders Atrial fibrillation	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Cardiac disorders Palpitations	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Cardiac disorders Sinus tachycardia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Ear and labyrinth disorders Tinnitus	11.1% 2/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Endocrine disorders Adrenal insufficiency	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Endocrine disorders Hyperthyroidism	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Endocrine disorders Hypothyroidism	16.7% 3/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	24.4% 11/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	11.8% 4/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Blurred vision	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Cataract	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Conjunctivitis	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Dry eye	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	8.9% 4/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Eye disorders - Other, specify	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Eye pain	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Eyelid function disorder	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Floaters	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Glaucoma	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Uveitis	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Eye disorders Watering eyes	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Abdominal distension	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Abdominal pain	16.7% 3/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	15.6% 7/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	29.4% 10/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Anal hemorrhage	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Ascites	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.2% 1/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Bloating	16.7% 3/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Cheilitis	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Colonic ulcer	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Constipation	44.4% 8/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	37.8% 17/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	47.1% 16/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Diarrhea	22.2% 4/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	22.2% 10/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	29.4% 10/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Dry mouth	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	5.9% 2/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	6.7% 3/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Enterocolitis	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Fecal incontinence	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	0.00% 0/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Flatulence	5.6% 1/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	4.4% 2/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	2.9% 1/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).
Gastrointestinal disorders Gastroesophageal reflux disease	16.7% 3/18 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	11.1% 5/45 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).	14.7% 5/34 • All-Cause Mortality measurement is assessed every 8-12 weeks during treatment. After protocol therapy then assessed annually until death, withdrawal of consent, or lost to follow-up. The observed maximum follow up 52 months (from overall survival). Adverse events(SAEs and OAEs) are assessed every 8-12 weeks. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 4(1-34). As such up to 136 weeks. A serious adverse event (SAE) is an undesirable sign, symptom, or medical condition which:is fatal;is life-threatening;requires or prolongs inpatient hospitalization for ≥24 hours;results in persistent or significant disability/incapacity to conduct normal life functions;constitutes a congenital anomaly or birth defect; or jeopardizes the participant and requires medical or surgical intervention to prevent one of the outcomes listed above; Remaining AEs are classified as Other AEs (OAEs).