Trial Outcomes & Findings for Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone (NCT NCT03660826)

Last Updated: 2025-11-12

Results Overview

Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

288 participants

Primary outcome timeframe

Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

Results posted on

2025-11-12

Participant Flow

Trial first activated on 09/04/2018 with reporting groups 1-3. It closed to accrual for reporting groups 1-3 on 06/17/2019. It reopened to accrual for reporting groups 4-7 on 08/16/2021. It closed to accrual for reporting groups 4-7 on 06/28/2023.

Participant milestones

Participant milestones
Measure	Arm I (Cediranib maleate_Reference Group 1) Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUG
Overall Study STARTED	40	40	40	42	42	43	41
Overall Study COMPLETED	40	40	40	42	42	43	41
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Cediranib maleate_Group1) n=40 Participants Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) n=40 Participants Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) n=40 Participants Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 Participants Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 Participants Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=43 Participants Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Group2) n=41 Participants Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Total n=288 Participants Total of all reporting groups
Age, Customized 80-89 years	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	2 Participants n=44 Participants	2 Participants n=8 Participants	3 Participants n=48 Participants	9 Participants n=18 Participants
Age, Customized 30-39 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	1 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	2 Participants n=18 Participants
Age, Customized 40-49 years	5 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants	1 Participants n=45 Participants	4 Participants n=44 Participants	2 Participants n=8 Participants	3 Participants n=48 Participants	18 Participants n=18 Participants
Age, Customized 50-59 years	5 Participants n=10 Participants	2 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	5 Participants n=44 Participants	6 Participants n=8 Participants	3 Participants n=48 Participants	24 Participants n=18 Participants
Age, Customized 60-69 years	20 Participants n=10 Participants	24 Participants n=10 Participants	25 Participants n=20 Participants	24 Participants n=45 Participants	23 Participants n=44 Participants	21 Participants n=8 Participants	20 Participants n=48 Participants	157 Participants n=18 Participants
Age, Customized 70-79 years	10 Participants n=10 Participants	13 Participants n=10 Participants	10 Participants n=20 Participants	14 Participants n=45 Participants	7 Participants n=44 Participants	12 Participants n=8 Participants	12 Participants n=48 Participants	78 Participants n=18 Participants
Sex: Female, Male Female	40 Participants n=10 Participants	40 Participants n=10 Participants	40 Participants n=20 Participants	42 Participants n=45 Participants	42 Participants n=44 Participants	43 Participants n=8 Participants	41 Participants n=48 Participants	288 Participants n=18 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants	2 Participants n=8 Participants	2 Participants n=48 Participants	9 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=10 Participants	39 Participants n=10 Participants	37 Participants n=20 Participants	41 Participants n=45 Participants	38 Participants n=44 Participants	39 Participants n=8 Participants	37 Participants n=48 Participants	271 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	1 Participants n=45 Participants	1 Participants n=44 Participants	2 Participants n=8 Participants	2 Participants n=48 Participants	8 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	1 Participants n=18 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants	2 Participants n=45 Participants	3 Participants n=44 Participants	1 Participants n=8 Participants	6 Participants n=48 Participants	15 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	5 Participants n=10 Participants	5 Participants n=10 Participants	4 Participants n=20 Participants	5 Participants n=45 Participants	4 Participants n=44 Participants	8 Participants n=8 Participants	5 Participants n=48 Participants	36 Participants n=18 Participants
Race (NIH/OMB) White	34 Participants n=10 Participants	31 Participants n=10 Participants	32 Participants n=20 Participants	34 Participants n=45 Participants	33 Participants n=44 Participants	31 Participants n=8 Participants	27 Participants n=48 Participants	222 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	3 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	2 Participants n=44 Participants	3 Participants n=8 Participants	3 Participants n=48 Participants	14 Participants n=18 Participants
Prior Immunotherapy No	36 Participants n=10 Participants	38 Participants n=10 Participants	35 Participants n=20 Participants	29 Participants n=45 Participants	29 Participants n=44 Participants	29 Participants n=8 Participants	28 Participants n=48 Participants	224 Participants n=18 Participants
Prior Immunotherapy Yes	4 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants	13 Participants n=45 Participants	13 Participants n=44 Participants	14 Participants n=8 Participants	13 Participants n=48 Participants	64 Participants n=18 Participants
Histology Serous	15 Participants n=10 Participants	16 Participants n=10 Participants	16 Participants n=20 Participants	17 Participants n=45 Participants	18 Participants n=44 Participants	13 Participants n=8 Participants	18 Participants n=48 Participants	113 Participants n=18 Participants
Histology Endometrioid, Grade 1	6 Participants n=10 Participants	2 Participants n=10 Participants	7 Participants n=20 Participants	5 Participants n=45 Participants	3 Participants n=44 Participants	9 Participants n=8 Participants	7 Participants n=48 Participants	39 Participants n=18 Participants
Histology Endometrioid, Grade 2	9 Participants n=10 Participants	6 Participants n=10 Participants	8 Participants n=20 Participants	11 Participants n=45 Participants	11 Participants n=44 Participants	10 Participants n=8 Participants	6 Participants n=48 Participants	61 Participants n=18 Participants
Histology Endometrioid, Grade 3	4 Participants n=10 Participants	11 Participants n=10 Participants	5 Participants n=20 Participants	6 Participants n=45 Participants	6 Participants n=44 Participants	10 Participants n=8 Participants	8 Participants n=48 Participants	50 Participants n=18 Participants
Histology Other	6 Participants n=10 Participants	5 Participants n=10 Participants	4 Participants n=20 Participants	3 Participants n=45 Participants	4 Participants n=44 Participants	1 Participants n=8 Participants	2 Participants n=48 Participants	25 Participants n=18 Participants

PRIMARY outcome

Timeframe: Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

Population: All patients randomized (Intent-to-Treat).

Outcome measures

Outcome measures
Measure	Arm I (Cediranib maleate_Reference Group 1) n=40 Participants Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) n=40 Participants Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) n=40 Participants Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 Participants Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 Participants Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=43 Participants Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=41 Participants Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Progression-free Survival	3.8 Months Interval 3.0 to 5.4	2.0 Months Interval 1.8 to 4.7	5.5 Months Interval 3.7 to 8.3	5.6 Months Interval 2.6 to 6.0	3.7 Months Interval 2.2 to 4.9	6.0 Months Interval 3.8 to 7.8	4.1 Months Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

Population: All patients randomized (Intent-to-Treat)

Overall survival is defined as the time from the date of study enrollment to the date of death regardless of cause. For those individuals who have no death reported at the time of the analysis, the censored time at risk will be assessed from the date of study enrollment to the date that the patient was last contacted and known to be alive.

Outcome measures

Outcome measures
Measure	Arm I (Cediranib maleate_Reference Group 1) n=40 Participants Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) n=40 Participants Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) n=40 Participants Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 Participants Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 Participants Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=43 Participants Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=41 Participants Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Overall Survival	12.4 Months Interval 7.5 to 22.9	13.4 Months Interval 6.5 to 19.5	17.6 Months Interval 9.3 to 21.2	16.9 Months Interval 9.3 to 20.3	14.0 Months Interval 10.4 to 20.3	22.6 Months Interval 13.1 to The number of events was not sufficient for the estimation of this parameter (i.e. upper limit of the CI)	16.6 Months Interval 8.5 to 20.6

SECONDARY outcome

Timeframe: Scans were done every 8 weeks for the first year; then every 12 weeks thereafter until disease progression is confirmed or up to 33 months.

Population: All patients who are eligible for response assessment.

Objective tumor response was assessed in patients with measurable disease by the site investigator using RECIST v1.1. Patients with complete or partial tumor response were considered to have a response.

Outcome measures

Outcome measures
Measure	Arm I (Cediranib maleate_Reference Group 1) n=29 Participants Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) n=32 Participants Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) n=35 Participants Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=38 Participants Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=32 Participants Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=34 Participants Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=30 Participants Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Objective Tumor Response	7 Participants	4 Participants	11 Participants	8 Participants	11 Participants	16 Participants	6 Participants

SECONDARY outcome

Timeframe: Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy up to 50 months.

Population: Patients who initiated assigned treatment.

The number of patients who reported at least a grade 3 adverse event were assessed in those who initiated treatment.

Outcome measures

Outcome measures
Measure	Arm I (Cediranib maleate_Reference Group 1) n=39 Participants Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm II (Olaparib) n=40 Participants Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm III (Cediranib Maleate, Olaparib) n=39 Participants Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 Participants Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 Participants Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=42 Participants Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=37 Participants Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
Incidence of Adverse Events	28 Participants	19 Participants	31 Participants	24 Participants	21 Participants	31 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Will assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib.

Outcome measures

Outcome data not reported

Adverse Events

Arm II (Olaparib)

Serious events: 12 serious events

Other events: 40 other events

Deaths: 26 deaths

Arm I (Cediranib maleate_Reference Group 1)

Serious events: 17 serious events

Other events: 38 other events

Deaths: 23 deaths

Arm III (Cediranib Maleate, Olaparib)

Serious events: 19 serious events

Other events: 39 other events

Deaths: 20 deaths

Arm IV (Olaparib, Capivasertib)

Serious events: 11 serious events

Other events: 41 other events

Deaths: 27 deaths

Arm V (Olaparib, Durvalumab)

Serious events: 16 serious events

Other events: 42 other events

Deaths: 28 deaths

Arm VI (Cediranib Maleate, Durvalumab)

Serious events: 13 serious events

Other events: 40 other events

Deaths: 21 deaths

Arm VII (Cediranib maleate_Reference Group 2)

Serious events: 19 serious events

Other events: 37 other events

Deaths: 27 deaths

Serious adverse events

Serious adverse events
Measure	Arm II (Olaparib) n=40 participants at risk Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm I (Cediranib maleate_Reference Group 1) n=39 participants at risk Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm III (Cediranib Maleate, Olaparib) n=39 participants at risk Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 participants at risk Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 participants at risk Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=42 participants at risk Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=37 participants at risk Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUG
Blood and lymphatic system disorders Febrile Neutropenia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Anemia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Myocardial Infarction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Diarrhea	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colonic Fistula	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Vomiting	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Small Intestinal Perforation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Rectal Hemorrhage	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colonic Obstruction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Small Intestinal Obstruction	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Nausea	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Ascites	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Abdominal Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Dyspepsia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Fever	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders General Disorders And Administration Site Conditio	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Fatigue	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Edema Limbs	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Death Nos	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Hepatobiliary disorders Hepatic Failure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Hepatobiliary disorders Cholecystitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Urinary Tract Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Skin Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Sepsis	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Upper Respiratory Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Weight Loss	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Lymphocyte Count Decreased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Ggt Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Creatinine Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Alanine Aminotransferase Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Activated Partial Thromboplastin Time Prolonged	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Dehydration	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Anorexia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Soft Tissue Necrosis Lower Limb	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment Related Secondary Malignancy	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Tremor	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Syncope	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Stroke	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Spinal Cord Compression	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Seizure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Muscle Weakness Left-Sided	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Headache	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Dysphasia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Reversible Posterior Leukoencephalopathy Syndrome	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Dysarthria	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Transient Ischemic Attacks	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Delusions	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Confusion	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Vaginal Hemorrhage	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Thromboembolic Event	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hypotension	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hypertension	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.

Other adverse events

Other adverse events
Measure	Arm II (Olaparib) n=40 participants at risk Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm I (Cediranib maleate_Reference Group 1) n=39 participants at risk Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm III (Cediranib Maleate, Olaparib) n=39 participants at risk Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm IV (Olaparib, Capivasertib) n=42 participants at risk Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm V (Olaparib, Durvalumab) n=42 participants at risk Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO	Arm VI (Cediranib Maleate, Durvalumab) n=42 participants at risk Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA	Arm VII (Cediranib maleate_Reference Group 2) n=37 participants at risk Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUG
Blood and lymphatic system disorders Leukocytosis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Lymph Node Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Palpitations	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Supraventricular Tachycardia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Sinus Bradycardia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Febrile Neutropenia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Blood and lymphatic system disorders Anemia	67.5% 27/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	30.8% 12/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	57.1% 24/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	50.0% 21/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Pericardial Effusion	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Myocardial Infarction	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Atrial Fibrillation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Sinus Tachycardia	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Cardiac Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Chest Pain - Cardiac	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Cardiac disorders Heart Failure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Ear and labyrinth disorders Ear And Labyrinth Disorders - Other	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Ear and labyrinth disorders Hearing Impaired	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Ear and labyrinth disorders Vertigo	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Ear and labyrinth disorders Ear Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Ear and labyrinth disorders Tinnitus	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Hyperparathyroidism	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Endocrine Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Hypoparathyroidism	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Adrenal Insufficiency	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Hyperthyroidism	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Endocrine disorders Hypothyroidism	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	28.2% 11/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	28.6% 12/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	48.6% 18/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Vision Decreased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Eye Disorders - Other	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Dry Eye	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Flashing Lights	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Eye Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Blurred Vision	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Cataract	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Eye disorders Watering Eyes	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Diarrhea	25.0% 10/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	76.9% 30/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	66.7% 26/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	73.8% 31/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	61.9% 26/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	83.8% 31/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Dry Mouth	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Constipation	22.5% 9/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.1% 9/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	28.2% 11/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	33.3% 14/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	32.4% 12/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Dental Caries	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colonic Fistula	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Cheilitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Vomiting	20.0% 8/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	41.0% 16/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.9% 14/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.7% 15/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	28.6% 12/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Stomach Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Toothache	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Obstruction Gastric	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Small Intestinal Perforation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Rectal Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Bloating	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Rectal Hemorrhage	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Colonic Obstruction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Abdominal Distension	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Periodontal Disease	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Pancreatitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Small Intestinal Obstruction	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Oral Hemorrhage	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Nausea	60.0% 24/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	56.4% 22/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	71.8% 28/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	69.0% 29/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	47.6% 20/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	42.9% 18/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	67.6% 25/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Dysphagia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Mucositis Oral	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.1% 9/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	29.7% 11/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gastroesophageal Reflux Disease	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Hemorrhoids	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Fecal Incontinence	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gingival Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Oral Dysesthesia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Ascites	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Oral Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Anal Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Flatulence	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Abdominal Pain	20.0% 8/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	33.3% 13/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	33.3% 14/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	32.4% 12/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gastritis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Ileus	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Esophagitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Gastrointestinal Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Belching	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Anal Ulcer	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Gastrointestinal disorders Dyspepsia	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Pain	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Malaise	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Flu Like Symptoms	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Fever	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders General Disorders And Administration Site Conditio	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Fatigue	70.0% 28/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	64.1% 25/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	74.4% 29/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	71.4% 30/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	52.4% 22/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	52.4% 22/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	62.2% 23/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Gait Disturbance	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Edema Trunk	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Non-Cardiac Chest Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Edema Limbs	20.0% 8/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Edema Face	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Localized Edema	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
General disorders Chills	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Hepatobiliary disorders Hepatic Failure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Hepatobiliary disorders Cholecystitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Immune system disorders Immune System Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Wound Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Immune system disorders Allergic Reaction	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Vulval Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Tooth Infection	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Urinary Tract Infection	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	17.9% 7/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Thrush	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Vaginal Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Skin Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Sinusitis	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Shingles	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Sepsis	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Rhinitis Infective	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Rash Pustular	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Pleural Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Papulopustular Rash	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Nail Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Mucosal Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Lung Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Infections And Infestations - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Folliculitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Herpes Simplex Reactivation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Upper Respiratory Infection	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Bronchial Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Infections and infestations Bladder Infection	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Vascular Access Complication	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Fracture	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Fall	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Wound Complication	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Dermatitis Radiation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Bruising	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Weight Loss	15.0% 6/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	38.5% 15/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.9% 14/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	29.7% 11/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Weight Gain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Thyroid Stimulating Hormone Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Serum Amylase Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Platelet Count Decreased	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	20.5% 8/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Neutrophil Count Decreased	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Lymphocyte Count Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Lymphocyte Count Decreased	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	28.6% 12/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Investigations - Other	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Inr Increased	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Hemoglobin Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Ggt Increased	17.5% 7/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Creatinine Increased	25.0% 10/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.9% 14/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	42.9% 18/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	19.0% 8/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Cholesterol High	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Lipase Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Cardiac Troponin T Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Blood Lactate Dehydrogenase Increased	17.5% 7/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Blood Bilirubin Increased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations White Blood Cell Decreased	25.0% 10/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Blood Bicarbonate Decreased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Aspartate Aminotransferase Increased	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	29.7% 11/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Alkaline Phosphatase Increased	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	19.0% 8/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	29.7% 11/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Alanine Aminotransferase Increased	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	24.3% 9/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Investigations Activated Partial Thromboplastin Time Prolonged	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Obesity	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Metabolism And Nutrition Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypophosphatemia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyponatremia	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	19.0% 8/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	24.3% 9/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypokalemia	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.1% 9/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	17.9% 7/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	19.0% 8/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.6% 8/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypocalcemia	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypoalbuminemia	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypomagnesemia	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.9% 14/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	30.8% 12/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	24.3% 9/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	17.9% 7/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Glucose Intolerance	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Dehydration	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	20.5% 8/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.6% 8/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Metabolism and nutrition disorders Anorexia	30.0% 12/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	41.0% 16/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	41.0% 16/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.7% 15/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	54.1% 20/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Back Pain	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.1% 9/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Avascular Necrosis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Soft Tissue Necrosis Lower Limb	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Pain In Extremity	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	24.3% 9/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder - O	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Muscle Weakness Trunk	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Muscle Cramp	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Joint Range Of Motion Decreased	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Syncope	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment Related Secondary Malignancy	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Tremor	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Stroke	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Spinal Cord Compression	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Somnolence	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Seizure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Peripheral Sensory Neuropathy	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Neuralgia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Nervous System Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Memory Impairment	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Headache	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	41.0% 16/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	26.2% 11/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	48.6% 18/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Paresthesia	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Presyncope	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Reversible Posterior Leukoencephalopathy Syndrome	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Dysgeusia	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Dysarthria	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Dizziness	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.6% 8/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Concentration Impairment	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Transient Ischemic Attacks	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Nervous system disorders Amnesia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Psychiatric Disorders - Other	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Insomnia	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	19.0% 8/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Hallucinations	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Depression	12.5% 5/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Delusions	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Confusion	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Anxiety	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Psychiatric disorders Agitation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Tract Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Retention	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Frequency	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Fistula	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Renal Calculi	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Renal And Urinary Disorders - Other	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Proteinuria	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.2% 6/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Incontinence	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Urinary Urgency	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Hematuria	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Glucosuria	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Dysuria	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Cystitis Noninfective	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Bladder Spasm	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Renal and urinary disorders Acute Kidney Injury	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Vaginal Hemorrhage	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	16.7% 7/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Vaginal Discharge	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Uterine Hemorrhage	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Perineal Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Pelvic Pain	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Vaginal Fistula	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Vaginal Pain	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Dyspareunia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Reproductive system and breast disorders Breast Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Voice Alteration	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	15.4% 6/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	13.5% 5/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Laryngeal Hemorrhage	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Laryngeal Edema	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	17.9% 7/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	35.1% 13/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.5% 11/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	20.5% 8/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	20.5% 8/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	31.0% 13/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.6% 8/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Cough	22.5% 9/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	17.9% 7/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	25.6% 10/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	11.9% 5/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	23.8% 10/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Bronchial Obstruction	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Skin Ulceration	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	21.4% 9/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	12.8% 5/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.4% 2/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Rash Acneiform	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	18.9% 7/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Nail Ridging	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Nail Loss	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Scalp Pain	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Nail Changes	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Dry Skin	5.0% 2/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Skin and subcutaneous tissue disorders Alopecia	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Surgical and medical procedures Surgical And Medical Procedures - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.7% 1/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Vascular Disorders - Other	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Thromboembolic Event	10.0% 4/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	5.1% 2/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Peripheral Ischemia	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Lymphedema	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hypotension	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.7% 3/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.3% 4/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	7.1% 3/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	10.8% 4/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hypertension	22.5% 9/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	74.4% 29/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	79.5% 31/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	9.5% 4/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	14.3% 6/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	45.2% 19/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	70.3% 26/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hot Flashes	0.00% 0/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.6% 1/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	4.8% 2/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	8.1% 3/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Hematoma	2.5% 1/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.
Vascular disorders Flushing	7.5% 3/40 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/39 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	2.4% 1/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/42 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.	0.00% 0/37 • Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months. Patients randomized were included for the all-cause mortality summary. Patients randomized and also initiated treatment were included for the AE/SAE summary.

Additional Information

Helen Huang on behalf of Danielle Enserro, PhD.

NRG Oncology

Phone: (716) 845-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60