Trial Outcomes & Findings for Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer (NCT NCT04034927)

NCT ID: NCT04034927

Last Updated: 2025-09-22

Results Overview

The count of participants who have progressed or died (death due to any cause). Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Summary of RECIST 1.1 criteria for progression for this trial: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: PFS is monitored for progression or death due to any cause, whichever occurs first. The median follow-up time is 22 months. Since the study was stopped early, the follow-up for progression-free survival was significantly reduced.
• Results posted on: 2025-09-22

Participant Flow

GY021 was opened to accrual in October of 2019. The study enrolled 61 patients from December of 2019 through March of 2021. Then the study was suspended.

Participant milestones

Measure	Arm I (Olaparib) Patients receive olaparib (300 mg) PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) Patients receive olaparib (300 mg) twice daily until disease progression or adverse events prohibit further treatment. Patients also receive tremelimumab (750 mg)\* IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. \*If a patient's weight falls to less than or equal to 30 kg, the patient should receive weight-based dosing equivalent to 10 mg/kg of tremelimumab every 4 weeks. Olaparib: Given PO Tremelimumab: Given IV
Overall Study STARTED	30	31
Overall Study COMPLETED	23	16
Overall Study NOT COMPLETED	7	15

Reasons for withdrawal

Measure	Arm I (Olaparib) Patients receive olaparib (300 mg) PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) Patients receive olaparib (300 mg) twice daily until disease progression or adverse events prohibit further treatment. Patients also receive tremelimumab (750 mg)\* IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. \*If a patient's weight falls to less than or equal to 30 kg, the patient should receive weight-based dosing equivalent to 10 mg/kg of tremelimumab every 4 weeks. Olaparib: Given PO Tremelimumab: Given IV
Overall Study Adverse Event	4	9
Overall Study Death	0	1
Overall Study Withdrawal by Subject	0	3
Overall Study Still on Treatment	2	1
Overall Study Other	1	1

Baseline Characteristics

Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer

Baseline characteristics by cohort

Measure	Arm I (Olaparib) n=30 Participants Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=31 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV	Total n=61 Participants Total of all reporting groups
Age, Customized 20 - 29 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 30 - 39 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 40 - 49 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 50 - 59 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 60 - 69 years	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Age, Customized 70 - 79 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized >= 80 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: PFS is monitored for progression or death due to any cause, whichever occurs first. The median follow-up time is 22 months. Since the study was stopped early, the follow-up for progression-free survival was significantly reduced.

Population: All randomized patients (intent to treat)

The count of participants who have progressed or died (death due to any cause). Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Summary of RECIST 1.1 criteria for progression for this trial: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Arm I (Olaparib) n=30 Participants Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=31 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Progression Free Survival (PFS)	24 Participants	23 Participants

PRIMARY outcome

Timeframe: At least 4 weeks after initiating treatment, no longer than 12 weeks (three complete treatment cycles). Maximum follow-up was 12 weeks.

Population: All patients who initiated treatment on Arm II and either 1) experienced a DLT or 2) completed three cycles. Patients randomized to Arm I are excluded from DLT assessment.

The outcome measure presents the count of participants who experienced a DLT. If more than six of the first 25 patients treated with Tremelimumab and Olaparib are unable to complete at least 3 cycles of treatment due to DLTs then the study will be stopped. If not, then enrollment will continue until 45 patients are enrolled. If more than 11 of the first 45 patients treated with the combination regimen are unable to complete the first 3 cycles of treatment, then enrollment will be stopped, otherwise, the trial till proceed to the third component (i.e. a phase 2 comparison of study treatments).

Outcome measures

Measure	Arm I (Olaparib) Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=25 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Dose-limiting Toxicity (DLT) (Safety Lead-In)	0 Participants	6 Participants

SECONDARY outcome

Timeframe: The median follow-up is 22 months. Since the study was stopped early, the follow-up time frame for objective response was significantly reduced.

Population: All randomized patients (intent to treat).

The objective response (RECIST 1.1) is the count of subjects with a best overall complete response (CR) or partial response (PR) among those with target lesions at the time of enrollment. : Summary of RECIST 1.1 criteria for progression for this trial: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Arm I (Olaparib) n=30 Participants Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=31 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Objective Response (RECIST 1.1)	11 Participants	9 Participants

SECONDARY outcome

Timeframe: Overall survival will be monitored from enrollment to randomization to the date of death due to any cause. The median follow-up is 22 months. Since the study was stopped early, the time frame for OS follow-up was significantly reduced.

Population: All randomized patients (intent-to-treat).

Overall survival (OS) will be presented as survival events (deaths).

Outcome measures

Measure	Arm I (Olaparib) n=30 Participants Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=31 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Number of Participants Died	9 Participants	11 Participants

SECONDARY outcome

Timeframe: During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: survival is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events.

Population: All randomized patients who initiated treatment

Safety data will be summarized for all treated subjects. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. This will be presented as the count of participants who experienced an adverse event (AE) of grade 3 or higher.

Outcome measures

Measure	Arm I (Olaparib) n=30 Participants Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=30 Participants Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Number of Participants With Adverse Event of Grade 3 or Higher	15 Participants	20 Participants

Adverse Events

Arm I (Olaparib)

Serious events: 15 serious events

Other events: 30 other events

Deaths: 9 deaths

Arm II (Olaparib, Tremelimumab)

Serious events: 20 serious events

Other events: 30 other events

Deaths: 11 deaths

Serious adverse events

Measure	Arm I (Olaparib) n=30 participants at risk Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=30 participants at risk Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Blood and lymphatic system disorders Anemia	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Cardiac disorders Sinus Bradycardia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Cardiac disorders Atrial Fibrillation	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Adrenal Insufficiency	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Diarrhea	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Constipation	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Colitis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Vomiting	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Abdominal Distension	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Small Intestinal Obstruction	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Nausea	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Peritoneal Necrosis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Abdominal Pain	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Fatigue	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Edema Limbs	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Generalized Edema	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Immune system disorders Autoimmune Disorder	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Urinary Tract Infection	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Sepsis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Lung Infection	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Appendicitis Perforated	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Platelet Count Decreased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Neutrophil Count Decreased	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Lymphocyte Count Decreased	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Electrocardiogram Qt Corrected Interval Prolonged	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations White Blood Cell Decreased	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Alanine Aminotransferase Increased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Dehydration	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Anorexia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Syncope	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Stroke	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Seizure	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Psychiatric disorders Psychosis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Acute Kidney Injury	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Reproductive system and breast disorders Pelvic Pain	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Thromboembolic Event	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Hypertension	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.

Other adverse events

Measure	Arm I (Olaparib) n=30 participants at risk Patients receive olaparib PO BID in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO	Arm II (Olaparib, Tremelimumab) n=30 participants at risk Patients receive olaparib as in Arm I. Patients also receive tremelimumab IV over 60 minutes on day 1. Cycles of tremelimumab repeat every 4 weeks for 4 doses and then every 12 weeks for up to 2 years total in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO Tremelimumab: Given IV
Blood and lymphatic system disorders Anemia	63.3% 19/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	56.7% 17/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Blood and lymphatic system disorders Eosinophilia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Cardiac disorders Palpitations	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Cardiac disorders Sinus Tachycardia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Ear and labyrinth disorders Vertigo	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Ear and labyrinth disorders Tinnitus	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Adrenal Insufficiency	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Hyperthyroidism	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Hypophysitis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Hypothyroidism	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Endocrine disorders Hypopituitarism	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Eye disorders Blurred Vision	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Diarrhea	26.7% 8/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	50.0% 15/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Dry Mouth	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Constipation	33.3% 10/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Colitis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Vomiting	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	33.3% 10/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Stomach Pain	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Rectal Pain	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Bloating	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Rectal Hemorrhage	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Abdominal Distension	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Nausea	50.0% 15/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	70.0% 21/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Dysphagia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Mucositis Oral	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Hemorrhoids	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Fecal Incontinence	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Oral Dysesthesia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Flatulence	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Abdominal Pain	26.7% 8/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Gastrointestinal Pain	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Belching	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Gastrointestinal disorders Dyspepsia	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Pain	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Flu Like Symptoms	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Fever	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Fatigue	60.0% 18/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	50.0% 15/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Non-Cardiac Chest Pain	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Edema Limbs	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Edema Face	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Chills	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
General disorders Generalized Edema	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Immune system disorders Autoimmune Disorder	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Tooth Infection	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Urinary Tract Infection	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Thrush	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Vaginal Infection	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Skin Infection	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Shingles	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Sepsis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Otitis Externa	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Eye Infection	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Infections and infestations Upper Respiratory Infection	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Injury, poisoning and procedural complications Fracture	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Injury, poisoning and procedural complications Burn	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Weight Loss	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Weight Gain	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Thyroid Stimulating Hormone Increased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Platelet Count Decreased	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Neutrophil Count Decreased	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Lymphocyte Count Decreased	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Hemoglobin Increased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Electrocardiogram Qt Corrected Interval Prolonged	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Creatinine Increased	40.0% 12/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	36.7% 11/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Cardiac Troponin T Increased	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Cardiac Troponin I Increased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Blood Lactate Dehydrogenase Increased	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Blood Bilirubin Increased	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations White Blood Cell Decreased	36.7% 11/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Aspartate Aminotransferase Increased	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Alkaline Phosphatase Increased	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Alanine Aminotransferase Increased	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Investigations Activated Partial Thromboplastin Time Prolonged	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hyponatremia	26.7% 8/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypokalemia	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypoalbuminemia	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypomagnesemia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypernatremia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hyperglycemia	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Hypercalcemia	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Metabolism and nutrition disorders Anorexia	30.0% 9/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	30.0% 9/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Back Pain	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Pain In Extremity	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Neck Pain	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Myositis	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Muscle Cramp	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Syncope	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Stroke	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Peripheral Sensory Neuropathy	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Peripheral Motor Neuropathy	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Memory Impairment	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Lethargy	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Headache	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	36.7% 11/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Dysgeusia	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Nervous system disorders Dizziness	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	16.7% 5/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Psychiatric disorders Insomnia	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Psychiatric disorders Depression	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Psychiatric disorders Confusion	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Psychiatric disorders Anxiety	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Tract Pain	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Tract Obstruction	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Retention	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Frequency	13.3% 4/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Renal Calculi	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Proteinuria	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Incontinence	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Urinary Urgency	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Hematuria	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Renal and urinary disorders Dysuria	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Reproductive system and breast disorders Pelvic Pain	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Sore Throat	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Laryngeal Hemorrhage	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	23.3% 7/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Rash Acneiform	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Skin and subcutaneous tissue disorders Alopecia	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Thromboembolic Event	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Hypotension	10.0% 3/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Hypertension	20.0% 6/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	6.7% 2/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.
Vascular disorders Flushing	0.00% 0/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.	3.3% 1/30 • During treatment period and up to 30 days after treatment end. The mean follow-up for adverse events was 6.4 months. Note: overall survival (OS) is monitored for a longer period of time (i.e. up to five years) as compared to the period for collecting adverse events. The treatment period ends when the patient progresses or an adverse event prevents further treatments. Once the treatment period ends, adverse events will only be collected for an additional 30 days. All adverse events, including severe adverse events (SAEs) and treatment-related adverse events, will be categorized and graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. There is one less patient in the AE/SAE section than in the All Cause Mortality section. This is due to one patient never being treated. Therefore this patient is excluded from adverse events, however this patient was still followed for survival status.

Additional Information

Christopher Purdy on behalf of Danielle Enserro, PhD

NRG Oncology

Phone: (716) 845-1300

Email: purdyc@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60